A Pilot Study of Neoadjuvant Chemotherapy With Selective Use of Radiation for Locally Advanced Rectal Cancer
- Determine whether neoadjuvant chemotherapy comprising oxaliplatin, fluorouracil,
leucovorin calcium (FOLFOX), and bevacizumab can be substituted for pelvic radiotherapy
without compromising R0 resection rates in patients with locally advanced rectal
- Determine whether a 3-year local recurrence rate of ≤ 10% can be achieved in patients
treated with this regimen.
- Determine the proportion of patients who achieve a complete pathologic response after
treatment with this regimen.
OUTLINE: This is a non-randomized, open-label, pilot study.
- Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours, leucovorin
calcium IV over 2 hours, and bevacizumab IV over 10 minutes on day 1 and fluorouracil
IV continuously over 48 hours on days 1 and 2 in weeks 1, 3, 5, and 7. Patients then
receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and
fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 9 and 11. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Within 3 weeks after completion of neoadjuvant chemotherapy, patients undergo restaging
evaluation. Patients with no evidence of disease progression by endorectal ultrasound
(ERUS), pelvic MRI, and CT scan of the chest/abdomen AND who remain candidates for R0
resection may proceed directly to surgical resection within 4-6 weeks after completion of
neoadjuvant chemotherapy. Patients with progressive disease who are not candidates for an R0
resection, proceed to neoadjuvant chemoradiotherapy.
- Neoadjuvant chemoradiotherapy: Patients undergo pelvic radiotherapy 5 days a week and
receive concurrent fluorouracil IV continuously for 5½ weeks. Within 4-7 weeks after
completion of chemoradiotherapy, patients undergo surgical resection.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
R0 resection rate
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|