Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00268333
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

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 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.

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 radiotherapy and concurrent fluorouracil and oxaliplatin.

Secondary

* Determine the overall survival and disease-free survival of patients treated with this regimen.

* Determine the primary site of recurrence and time to recurrence in patients treated with this regimen.

* Determine quality of life of patients treated with this regimen.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

* Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients with stable or responding disease proceed to chemoradiotherapy.

* Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5 weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks beginning on day 1.

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-22
• Primary Completion: 2006-01
• Status Verified: 2007-05
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival
Disease-free survival
Primary site of recurrence
Time to recurrence
Quality of life

Trial Locations

Locations (9)

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Hopital Drevon; 🇫🇷 Dijon, France

Hopital Robert Boulin; 🇫🇷 Libourne, France

Polyclinique des Quatre Pavillons; 🇫🇷 Lormont, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Polyclinique De Courlancy; 🇫🇷 Reims, France

C.H. Senlis; 🇫🇷 Senlis, France