Status:
COMPLETED
Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radio...
Eligibility Criteria
Inclusion
- 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:
- Peri-uretal
- Liver
- Iliac
- Clavicle
- Mediastinum
- Inguinal
- Cervical
- Incompletely resected disease
- Recurrent disease, defined by 1 of the following criteria:
- Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin
- Progressive disease after cisplatin or fluorouracil
- Must be able to be encompassed in radiation field
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy more than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000 /mm\^3
- Alkaline phosphatase ≤ 5 times normal
- Bilirubin ≤ 2 times normal
- Creatinine \< 2 times normal or creatinine clearance ≥ 40 mL/min
- No peripheral neuropathy \> grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No weight loss \> 15% since diagnosis of recurrent disease
- No uncontrolled heart disease
- No angina
- No symptomatic disease of the inferior artery
- No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
- No concurrent corticosteroids
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00268333
Start Date
August 1 2005
Last Update
February 9 2009
Active Locations (9)
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1
Institut Sainte Catherine
Avignon, France, 84082
2
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France, 25030
3
Hopital Drevon
Dijon, France, 21000
4
Hopital Robert Boulin
Libourne, France, 33500