A Pilot Study of Neoadjuvant Chemotherapy With Selective Use of Radiation for Locally Advanced Rectal Cancer
OBJECTIVES:
Primary
- 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
cancer.
Secondary
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
R0 resection rate
3 years
No
Leonard B. Saltz, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
07-021
NCT00462501
March 2007
December 2013
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |