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Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | Experimental | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
|
| Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | Experimental | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5FU | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Tumor Downstaging Compared With Historical Controls. | Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%. | 1 year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rates | Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0). Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0). pCR rate of historical controls is 8%-14%. | 1 year after enrollment |
Not provided
Inclusion Criteria:
Biopsy proven adenocarcinoma of the rectum
Lesion evaluated by surgeon and found to be resectable
Stage T3 or T4 disease on radiography or ultrasound
Karnofsky Performance Status at >60
Laboratory criteria:
Informed consent signed
Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Tan, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Enrollment to the study opened on 10/07/2002 and the study closed to enrollment on 10/23/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
| FG001 | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Good Risk (TYMS*2/*2, *2/*3, *2/*4) | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
| BG001 | Poor Risk (TYMS*3/*3, *3/*4) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Rate of Tumor Downstaging Compared With Historical Controls. | Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%. | 8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX 6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year after enrollment |
|
Beginning of treatment through 30 days after the end of surgery.
Two patients in both the "Good Risk Arm" and the "Poor Risk Arm" withdrew consent and are not included.
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 | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes (total WBC) | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin R. Tan, M.D. | Washington University School of Medicine | 314-362-3560 | btan@dom.wustl.edu |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D011827 | Radiation |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Radiation | Radiation |
|
| Surgery of resectable lesions | Procedure |
|
| Irinotecan | Drug |
|
|
| Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation. |
The questionnaire is encouraged but not required. |
| Prior to start of study treatment and 3-6 weeks post completion of radiation therapy |
| Determine Patient Fears and Expectations of Pharmacogenetics. | The questionnaire is encouraged but not required. | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy |
Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Thymidylate Synthase Enhancer Region (TSER) genotype | Number | participants |
|
| Performance status | Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 Fully active able to carry on all predisease performance without restriction
| Number | participants |
|
| Baseline Stage |
Numbers or letters appear after T, N, and M to provide more details about each of these factors. The numbers 0 through 4 indicate increasing severity. The letter X means "cannot be assessed because the information is not available." | Number | participants |
|
| Baseline clinical T stage | Number | participants |
|
| Baseline clinical N stage | Number | participants |
|
| Baseline clinical M stage | Number | participants |
|
| Clinical staging modality | Number | participants |
|
| Tumor distance from anal verge (cm) | Number | participants |
|
| Tumor grade | Number | participants |
|
| OG001 | Poor Risk (TYMS*3/*3, *3/*4) | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
|
|
| Secondary | Complete Response Rates | Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0). Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0). pCR rate of historical controls is 8%-14%. | 8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX 6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician | Posted | Number | percentage of participants | 1 year after enrollment |
|
|
|
| Secondary | Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation. | The questionnaire is encouraged but not required. | The data was not collected for this outcome measure as the questionnaire was encouraged but not required. | Posted | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy |
|
|
| Secondary | Determine Patient Fears and Expectations of Pharmacogenetics. | The questionnaire is encouraged but not required. | The data was not collected for this outcome measure as the questionnaire was encouraged but not required. | Posted | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy |
|
|
| Post-Hoc | Toxicities by Genotype Group (Good Risk Versus Poor Risk) | Grade 3 to 4 toxicities related to treatment and surgery using CTC Version 2.0. | Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Overall Survival | Analyzed using Kaplan-Meier Models. | Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included. | Posted | Number | percentage of participants | 1 year, 2 years, and 3 years |
|
|
|
| Post-Hoc | Relapse-free Survival | Analyzed using Kaplan-Meier Models. | 14 patients in the Good Risk arm had metastatic rectal cancer at time of enrollment are not included in this analyses. 3 patients in the Poor Risk arm had metastatic rectal disease before surgery and are included in this analyses. 2 of the patients in the Good Risk arm and Poork Risk arm withdrew consent and are not included. | Posted | Number | percentage of participants | 1 year, 2 years, and 3 years |
|
|
|
| Post-Hoc | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. MTHFR gene = methylenetetrahydrofolate reductase (NAD(P)H) | 2 of the patients in the Good Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Poor Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Good Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Poor Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Good Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Poor Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Good Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| Post-Hoc | Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group) | Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit. | 2 of the patients in the Poor Risk arm withdrew consent and are not included. | Posted | Number | participants | First day of treatment through 30 days after completion of surgery |
|
|
|
| 16 |
| 96 |
| 96 |
| 96 |
| EG001 | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. | 12 | 35 | 35 | 35 |
| Diarrhea/RT enteritis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Perforation/abscess/leak fistula | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastrointestinal bleed | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anemia-blood transfusion | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hernia repair | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Crohn's flare | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Aneurysmal bleed | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Indigestion/cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Tenesmus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rectal spasms | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Flatus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis/mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Ileitis/Ileus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Bleeding-GI | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Bilirubin - increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| SGOT/SGPT - increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Alkaline phosphatase - increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| BUN - increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Creatinine -increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE 2.0 | Systematic Assessment |
|
| Neuropathy - motor | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Mood alteration-depression | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
|
| Mood alteration-anxiety | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Tremors | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Chills | General disorders | CTCAE 2.0 | Systematic Assessment |
|
| Fever without infection | General disorders | CTCAE 2.0 | Systematic Assessment |
|
| Sweats | Investigations | CTCAE 2.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE 2.0 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE 2.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hypoprotenemia | Metabolism and nutrition disorders | CTCAE 2.0 | Systematic Assessment |
|
| Skin itching/irritation/rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
|
| Skin dryness | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE 2.0 | Systematic Assessment |
|
| Erythema/PPE | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
|
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | CTCAE 2.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | CTCAE 2.0 | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE 2.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | CTCAE 2.0 | Systematic Assessment |
|
| PT | Investigations | CTCAE 2.0 | Systematic Assessment |
|
| PTT | Investigations | CTCAE 2.0 | Systematic Assessment |
|
| Defibrillator malfunction | Investigations | CTCAE 2.0 | Systematic Assessment |
|
| Pain-rectum | Gastrointestinal disorders | CTCAE 2.0 | Systematic Assessment |
|
| Pain-head, headache | Nervous system disorders | CTCAE 2.0 | Systematic Assessment |
|
| Ocular/vision-eye discomfort | Eye disorders | CTCAE 2.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006571 |
| Heterocyclic Compounds |
| D055585 | Physical Phenomena |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| Diarrhea |
|
| Dehydration |
|
| Mucositis |
|
| GI bleed |
|
| Ileitis |
|
| Enteritis |
|
| Dyspnea |
|
| Neutropenia |
|
| Anemia |
|
| Pain |
|
| Perforation |
|
| Pelvic abscess |
|
| PPE |
|
| Crohn's flare |
|
| Syncope |
|
| Rash |
|
| Fatigue |
|
| Atrial fibrillation |
|
| Infection |
|
| Headache |
|
| Small bowel obstruction |
|
| 3 years |
|
| 3 years |
|
| TT (MTHFR 677C>T) |
|
| TT (MTHFR 677C>T) |
|
| CC (MTHFR 1298A>C) |
|
| CC (MTHFR 1298A>C) |
|
| 677T-1298A |
|
| 677T-1298A |
|
| CA-TA |
|
| CC-CC |
|
| CC-TA |
|
| CC-TC |
|
| TA-TA |
|
| CA-TA |
|
| CC-CC |
|
| CC-TA |
|
| CC-TC |
|
| TA-TA |
|