Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000350136 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical stage of tumor (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, within 1 week after completion of radiotherapy, within 1 week after completion of adjuvant chemotherapy (12 months), and then at 24 months.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemoradiation with irinotecan | Experimental | Patients receive neoadjuvant therapy comprising 45 Gy (1.8 Gy/fx) + 5.4 Gy boost (1.8 Gy/fx) radiation therapy (RT), oral capecitabine 1200mg/m^2/day 5 days/week during RT, and irinotecan 50 mg/m^2 IV for 1 hour days 1, 8, 22, 29. Surgery 4-8 weeks after RT. Postoperative chemotherapy beginning Day 1 postoperatively for nine 14-day cycles(folinic acid 400 mg/m^2 over 2 hours Day 1; 5-fluorouracil bolus 400 mg/m^2 IV push Day 1 plus 2400 mg/m^2 IV continuous infusion over 46 hours, beginning Day 1; and oxaliplatin 85 mg/m^2 IV over 2 hours Day 1) . |
|
| Neoadjuvant chemoradiation with oxaliplatin | Experimental | Patients receive neoadjuvant therapy comprising 45 Gy (1.8 Gy/fx) + 5.4 Gy boost (1.8 Gy/fx) radiation therapy (RT), oral capecitabine 1650mg/m^2/day 5 days/week during RT, and oxaliplatin 50 mg/m^2 IV for 2 hours days 1, 8, 15, 22, 29. Surgery 4-8 weeks after RT. Postoperative chemotherapy beginning Day 1 postoperatively for nine 14-day cycles(folinic acid 400 mg/m^2 over 2 hours Day 1; 5-fluorouracil bolus 400 mg/m^2 IV push Day 1 plus 2400 mg/m^2 IV continuous infusion over 46 hours, beginning Day 1; and oxaliplatin 85 mg/m^2 IV over 2 hours Day 1) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate | A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR. Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial. | After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate at 4 Years | Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. | From randomization to four years |
| Local-regional Failure Rate at 4 Years |
Not provided
Inclusion Criteria:
Adenocarcinoma of the rectum originating at or below 12 cm from the anal verge without evidence of distant metastases
Patient must be 18 years of age or greater.
Potentially resectable en bloc based upon surgeon evaluation
Clinical stages T3 or T4, based upon endorectal ultrasound, or physical examination (only acceptable for T4 lesions).
Absolute neutrophil count of > 1500 per microliter and platelet count > 100,000 per microliter; aspartate aminotransferase (AST) and alkaline phosphatase < 2.5 X upper limit of normal (ULN), bilirubin < = 1.5 ULN, calculated creatinine clearance > 50 ml/min using Cockcroft-Gault formula:
Zubrod performance status 0-2
No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix, or ductal carcinoma in situ of the breast. Previous invasive cancer permitted if disease free at least 5 years.
Signed study-specific informed consent prior to randomization
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neal J. Meropol, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States | ||
| Baptist-South Miami Regional Cancer Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21775070 | Result | Wong SJ, Winter K, Meropol NJ, Anne PR, Kachnic L, Rashid A, Watson JC, Mitchell E, Pollock J, Lee RJ, Haddock M, Erickson BA, Willett CG. Radiation Therapy Oncology Group 0247: a randomized Phase II study of neoadjuvant capecitabine and irinotecan or capecitabine and oxaliplatin with concurrent radiotherapy for patients with locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1367-75. doi: 10.1016/j.ijrobp.2011.05.027. Epub 2011 Jul 19. | |
| Result | Wong SJ, Moughan J, Meropol NJ, et al.: Efficacy endpoints of RTOG 0247: A randomized phase II study of neoadjuvant capecitabine (C) and irinotecan (I) or C and oxaliplatin (O) with concurrent radiation therapy (RT) for locally advanced rectal cancer. [Abstract] J Clin Oncol 29 (Suppl 15): A-3517, 2011. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Chemoradiation With Irinotecan | Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Capecitabine 1650 mg/m^2/day | Drug | 825 mg/m^2 q12 hours (1650 mg/m^2/day) orally 5 days per week during radiotherapy. |
|
| Capecitabine 1200 mg/m^2/day | Drug | 600 mg/m^2 q12 hours(1200 mg/m^2/day) orally 5 days per week during radiotherapy. |
|
| Irinotecan | Drug | 50mg/m^2 IV over 1 hour on days 1, 8, 22, and 29 |
|
|
| Oxaliplatin | Drug | 50mg/m^2 IV over 2 hours on days 1, 8, 15, 22, and 29 |
|
| Surgery | Procedure | All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon. |
|
| Folinic Acid | Drug | 400 mg/m^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles. |
|
|
| Fluorouracil | Drug | 5-fluorouracil bolus 400 mg/m^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles. 5-fluorouracil infusion 2400 mg/m^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles. |
|
|
| Oxaliplatin | Drug | 85 mg/m^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles. |
|
Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method. |
| From randomization to four years |
| Distant Failure Rate at 4 Years | Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method. | From randomization to four years |
| Second Primary Rate at 4 Years | Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method. | From randomization to four years |
| Disease-free Survival Rate at 4 Years | Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. | From randomization to four years |
| Number of Participants With Grade 3+ Treatment-related Adverse Events | Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment to end of follow-up. Maximum follow-up is 5.2 years. |
| Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively | Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment to surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation. If no surgery, then <= 90 days from start of treatment. |
| Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively | Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery. |
| Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens | End of study |
| Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL. | Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization |
| Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL. | Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy |
| Change From Baseline in QLQ-C30 Global Health Status Score at Two Years | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A negative number indicates improvement in symptoms. | Baseline and two years |
| Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation | The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Baseline and completion of chemoradiation approximately 6-8 weeks from randomization |
| Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy | The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy |
| Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years | The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Baseline and two years |
| Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation | The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization |
| Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy | The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Baseline and completion of post-operative chemotherapy, approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy |
| Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years | The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Baseline and two years |
| Miami |
| Florida |
| 33176 |
| United States |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | 08053 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| Neoadjuvant Chemoradiation With Oxaliplatin |
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. |
| Primary Endpoint Population | First 48 eligible patients accrued per arm after the protocol amendment |
|
| General Analysis Population | Eligible participants enrolled after the protocol ammendment |
|
| Full AE Population | All eligible patients including those enrolled prior to protocol amendment |
|
| Surgery | Eligible patients enrolled after the protocol amendment who had surgery |
|
| Global Health Status Score at End of CR | EORTC QLQ-C30 Global Health Status (GHS) Score at baseline and end of chemoradiation (CR) |
|
| GHS at End of Post-op CT | EORTC QLQ-C30 GHS Score at baseline and end of post-operative chemotherapy (CT) |
|
| GHS at Two Years | EORTC QLQ-C30 GHS Score at baseline and two years |
|
| GI Symptom Score at End of CR | EORTC QLQ-CR38 Gastro-Intestinal (GI) Symptom Score at baseline and end of chemoradiation |
|
| GI Symptom Score at End of Post-op CT | EORTC QLQ-CR38 GI Symptom Score at baseline and end of post-operative chemotherapy |
|
| GI Symptom Score at Two Years | EORTC QLQ-CR38 GI Symptom Score at baseline and two years |
|
| Defecation Symptom Score at End of CR | EORTC QLQ-CR38 Defecation Symptom Score at baseline and end of chemoradiation |
|
| DS Score at End of Post-op CT | EORTC QLQ-CR38 Defecation Symptom (DS) Score at baseline and end of post-operative chemotherapy |
|
| Defecation Symptom Score at Two Years | EORTC QLQ-CR38 Defecation Symptom Score at baseline and two years |
|
| COMPLETED | Subjects contributing any data to analysis are considered to have completed the study |
|
| NOT COMPLETED |
|
|
Eligible patients enrolled after the protocol ammendment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Chemoradiation With Irinotecan | Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. |
| BG001 | Neoadjuvant Chemoradiation With Oxaliplatin | Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Complete Response Rate | A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR. Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial. | For each arm the first 48 eligible enrolled after the protocol amendment. | Posted | Number | 95% Confidence Interval | percentage of participants | After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Survival Rate at 4 Years | Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. | Eligible patients enrolled after the protocol amendment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to four years |
|
| |||||||||||||||||||||||||||||
| Secondary | Local-regional Failure Rate at 4 Years | Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method. | Eligible patients enrolled after the protocol amendment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to four years |
| ||||||||||||||||||||||||||||||
| Secondary | Distant Failure Rate at 4 Years | Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method. | Eligible patients enrolled after the protocol amendment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to four years |
|
| |||||||||||||||||||||||||||||
| Secondary | Second Primary Rate at 4 Years | Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method. | Eligible patients enrolled after the protocol amendment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to four years |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease-free Survival Rate at 4 Years | Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. | Eligible patients enrolled after the protocol amendment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to four years |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3+ Treatment-related Adverse Events | Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Eligible patients enrolled after the protocol amendment | Posted | Count of Participants | Participants | From start of treatment to end of follow-up. Maximum follow-up is 5.2 years. |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively | Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Eligible patients enrolled after the protocol amendment | Posted | Count of Participants | Participants | From start of treatment to surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation. If no surgery, then <= 90 days from start of treatment. |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively | Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | Eligible patients enrolled after the protocol amendment who had surgery | Posted | Count of Participants | Participants | From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery. |
| |||||||||||||||||||||||||||||||
| Secondary | Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens | The data required for this analysis was not obtained and will not be obtained. | Posted | End of study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL. | Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and completion of chemoradiation | Posted | Mean | Standard Deviation | score on a scale | Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL. | Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and completion of post-operative chemotherapy | Posted | Mean | Standard Deviation | score on a scale | Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in QLQ-C30 Global Health Status Score at Two Years | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and two years | Posted | Mean | Standard Deviation | score on a scale | Baseline and two years |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation | The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of chemoradiation | Posted | Mean | Standard Deviation | score on a scale | Baseline and completion of chemoradiation approximately 6-8 weeks from randomization |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy | The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of post-operative chemotherapy | Posted | Mean | Standard Deviation | score on a scale | Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years | The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of post-operative chemotherapy | Posted | Mean | Standard Deviation | score on a scale | Baseline and two years |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation | The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and completion of chemoradiation | Posted | Mean | Standard Deviation | score on a scale | Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy | The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and completion of chemoradiation | Posted | Mean | Standard Deviation | score on a scale | Baseline and completion of post-operative chemotherapy, approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years | The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 "not at all" to 4 "very much" such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. | Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and two years | Posted | Mean | Standard Deviation | score on a scale | Baseline and two years |
|
Not provided
All eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Chemoradiation With Irinotecan | Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. | 37 | 70 | 70 | 70 | ||
| EG001 | Neoadjuvant Chemoradiation With Oxaliplatin | Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. | 36 | 68 | 67 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow - Other: | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other: | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Small intestinal stricture NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tooth development disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sudden death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ano-rectal infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other: | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC: Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Culture wound negative | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leak (including anastomotic), GI: Small bowel | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Radiation recall syndrome | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Coagulopathy | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/laboratory - Other: | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alkalosis NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthritis NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/soft tissue - Other: | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/genitourinary - Other: | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pelvic pain NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acne NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating increased | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow - Other: | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other: | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Radiation mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constitutional Symptoms - Other: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: limb: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Radiation recall syndrome | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/laboratory - Other: | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuralgia NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/genitourinary - Other: | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Localised exfoliation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Due to excessive GI adverse events in the first 35 patients, chemotherapy dosage was modified and the protocol was amended (treatment descriptions reflect the revision). Therefore the first 35 patients are not included in outcome measure results.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| D013514 | Surgical Procedures, Operative |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
| Male |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|