A Phase III Randomized Controlled Study of Neoadjuvant FOLFOX6 Treatment With or Without Radiation Compared to 5-Fu Based Chemoradiation in Treating Patients With Resectable Rectal Cancer
Primary Compare the objective response rate and the rate of local-regional relapse in
patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based
chemoradiotherapy or FOLFOX alone without radiation.
1. Compare the rate of pathologic complete response in patients treated with these
2. Determine the increase in the number of patients who are able to undergo
sphincter-saving surgery after treatment with these regimens.
3. Correlate genetic patterns and the presence or absence of specific tissue biomarkers
with response and prognosis in patients treated with these regimens.
4. Compare preoperative quality of life (QOL) of patients treated with oral capecitabine
versus continuous infusion with fluorouracil. pelvic auto-nerve function
5. Determine the impact of oxaliplatin on neurotoxicity in patients treated with these
6. Compare the toxic effects of these regimens in these patients.
7. Compare the convenience of care in patients treated with these regimens.
8. Determine the impact of the type of surgical management on QOL at 1 year
postoperatively in these patients.
OUTLINE: This is a randomized, multi-center study. Patients are stratified according to
participating center, gender, clinical tumor stage (stage II vs. stage III), and surgical
intent (sphincter saving vs. non-sphincter saving). Patients are randomized to 1 of 4
- Arm A: Patients receive fluorouracil IV continuously and undergo radiotherapy once
daily 5 days a week for 5-6 weeks.
- Arm B: Patients receive FOLFOX for 4 cycles and undergo radiotherapy as in arm I from
the second cycle of FOLFOX.
- Arm C: Patients receive FOLFOX for 4 cycles Within 4-6 weeks after the completion of
chemo radiotherapy, patients with responding or stable disease undergo surgery.
Patients with progressive disease are treated at the discretion of the investigator and
continue to be followed. Patients with progressive disease in arm III should received
Quality of life is assessed at baseline, at completion of chemo radiotherapy, and at 1 year
After completion of study treatment, patients are followed every 3 months for 2 years, and
then every 6 months for 3years.
PROJECTED ACCRUAL: A total of 495 patients will be accrued for this study within 5 years.
Eligibility Ages Eligible for Study: 18-75 Years old Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3-year disease free survival
Compare 3-year disease free survival in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or FOLFOX alone without radiation.
Jianping Wang, MD
Sun Yatsen University
China: Food and Drug Administration