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| ID | Type | Description | Link |
|---|---|---|---|
| 07-C-0111 |
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Slow, insufficient accrual.
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Background:
Objectives:
Eligibility:
-Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus, stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an National Cancer Institute (NCI) protocol
Design:
Participants undergo the following procedures:
Background:
Objectives:
Eligibility:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Markers of Tumor Burden and Radiation Toxicity | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specimen collection | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment | Here are the number of participants with specific tumor markers in stool, urine, or serum detected prior to treatment and after treatment to monitor the extent of residual disease. | Prior to treatment (baseline) and after treatment, up to 19 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Chronic Gastrointestinal Injury After Radiotherapy | Gastrointestinal injury after radiotherapy is influenced by radiation dose (i.e. radiation toxicity) delivered to abdominal organs and can result in gastrointestinal radiation toxicity. Early detection of radiation toxicity (i.e. inflammation, fibrosis) may lead to a good outcome for a participant and late detection and radiation toxicity in the intestinal wall may lead to a bad outcome for a participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Toxicity Criteria (CTC) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
EXCLUSION CRITERIA:
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Patients with gastrointestinal tumors that will receive radiation therapy at the National Institutes of Health (NIH) Clinical Center as part of their treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah E Citrin, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16514137 | Background | Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106. | |
| 2431533 | Background | Seamonds B, Yang N, Anderson K, Whitaker B, Shaw LM, Bollinger JR. Evaluation of prostate-specific antigen and prostatic acid phosphatase as prostate cancer markers. Urology. 1986 Dec;28(6):472-9. doi: 10.1016/0090-4295(86)90146-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant. |
| FG001 | Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant. |
| FG002 | Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment | Here are the number of participants with specific tumor markers in stool, urine, or serum detected prior to treatment and after treatment to monitor the extent of residual disease. | A minimum of 120 participants must be enrolled to perform analyses to determine specific tumor markers in stool, urine for this outcome measure. Because the study was prematurely terminated due to slow, insufficient accrual and requirements for enrolment, assays were not performed on the collected samples, thus no data is reported for this outcome measure. It would be inappropriate to report an analysis for this outcome measure based on the enrollment of 9 participants. | Posted | Prior to treatment (baseline) and after treatment, up to 19 months |
|
Date treatment consent signed to date off study, an average of 19 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah E. Citrin | National Cancer Institute | 301-496-5457 | citrind@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2007 | Nov 2, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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10 cc in one ethylenediamine tetraacetic acid (EDTA) tube for plasma for Transforming growth factor beta 1 (TGFbeta1); 24cc total in serum separator tube (SST) for serum for extra-cellular markers; Stool - at least 10 gram (gm) in a sterile collection cup (leukocyte markers); Urine - at least 15 cubic centimeter (cc) in a sterile collection cup
| After radiotherapy, up to 19 months |
| Date treatment consent signed to date off study, an average of 19 months |
| 2468274 | Background | Guillet J, Role C, Duc AT, Francois H. Prostate-specific antigen (PSA) in the management of 500 prostatic patients. Am J Clin Oncol. 1988;11 Suppl 2:S61-2. doi: 10.1097/00000421-198801102-00013. |
| BG001 | Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant. |
| BG002 | Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant. |
| OG001 | Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant. |
| OG002 | Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant. |
|
| Secondary | Number of Participants With Chronic Gastrointestinal Injury After Radiotherapy | Gastrointestinal injury after radiotherapy is influenced by radiation dose (i.e. radiation toxicity) delivered to abdominal organs and can result in gastrointestinal radiation toxicity. Early detection of radiation toxicity (i.e. inflammation, fibrosis) may lead to a good outcome for a participant and late detection and radiation toxicity in the intestinal wall may lead to a bad outcome for a participant. | A minimum of 120 participants must be enrolled to perform analyses to determine gastrointestinal injury for this outcome measure. Because the study was prematurely terminated due to slow, insufficient accrual, and requirements for enrolment, analyses were not performed, and no data is reported for this outcome measure. It would be inappropriate to report an analysis for this outcome measure based on the enrollment of 9 participants. | Posted | After radiotherapy, up to 19 months |
|
|
| Other Pre-specified | Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Toxicity Criteria (CTC) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, an average of 19 months |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda | Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D004066 |
| Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |