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| ID | Type | Description | Link |
|---|---|---|---|
| CHUL-BIO-COLON | |||
| INCA-RECF0356 |
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RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive 1 of 4 chemotherapy regimens:
After completion of study therapy, patients are followed periodically for 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | |||
| fluorouracil | Drug | |||
| irinotecan hydrochloride | Drug | |||
| leucovorin calcium | Drug | |||
| oxaliplatin | Drug | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Oncogenetic parameters | ||
| Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects |
| Measure | Description | Time Frame |
|---|---|---|
| Correlations between the pharmacogenetic and pharmacokinetic parameters | ||
| Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic colorectal cancer
Measurable metastatic disease > 1 cm by spiral CT scan or > 2 cm by other methods
Scheduled to receive first-line chemotherapy for metastatic disease
No inadequate or unusable tissue as the only tissue available
No known brain metastases or meningeal disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Tubiana-Mathieu, MD | Centre Hospital Regional Universitaire de Limoges | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33912999 | Derived | Deyme L, Barbolosi D, Mbatchi LC, Tubiana-Mathieu N, Ychou M, Evrard A, Gattacceca F. Population pharmacokinetic model of irinotecan and its four main metabolites in patients treated with FOLFIRI or FOLFIRINOX regimen. Cancer Chemother Pharmacol. 2021 Aug;88(2):247-258. doi: 10.1007/s00280-021-04255-9. Epub 2021 Apr 28. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic 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 |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| 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 |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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