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| ID | Type | Description | Link |
|---|---|---|---|
| GERCOR-C04-1 | |||
| EU-20568 | |||
| SANOFI-GERCOR-C04-1 |
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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the completion of study treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | |||
| leucovorin calcium | Drug | |||
| oxaliplatin | Drug | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Disease-free survival | ||
| Primary site of recurrence |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Metastatic disease isolated to the following lymph nodes:
Aortic
Interaortic
Celiomesenteric
Retroperitoneal, including the following sites:
Incompletely resected disease
Recurrent disease, defined by 1 of the following criteria:
Must be able to be encompassed in radiation field
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Mineur, MD | Institut Sainte Catherine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte Catherine | Avignon | 84082 | France | |||
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
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| Time to recurrence |
| Quality of life |
| Besançon |
| 25030 |
| France |
| Hopital Drevon | Dijon | 21000 | France |
| Hopital Robert Boulin | Libourne | 33500 | France |
| Polyclinique des Quatre Pavillons | Lormont | 33310 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Hopital Tenon | Paris | 75970 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| C.H. Senlis | Senlis | 60309 | France |
| 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 |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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