Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin
- 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.
- Determine the overall survival and disease-free survival of patients treated with this
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Laurent Mineur, MD
Institut Sainte Catherine
United States: Federal Government