An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
In recent randomized studies with preoperative combined chemotherapy and external beam
radiation (EBRT/CT) with total mesorectal excision (TME surgery), the compliance to adjuvant
chemotherapy ranged from 42.9% to 70%. This low compliance rate could influence the efficacy
of chemotherapy. This is quite unique to patients with rectal cancer, since compliance is
not a major issue in patients with colon cancer, belonging to the same age group. Therefore,
it is reasonable to postulate that this difference might due to the additive toxicity burden
of neoadjuvant EBRT/CT and TME.
In this randomized phase II study, compliance to chemotherapy will be compared in the two
groups: In the first group, patients will receive half of their chemotherapy regimen in
neoadjuvant and half in adjuvant; and, in the second group, patients will be receiving all
their chemotherapy in adjuvant. Furthermore, brachytherapy will be used to deliver
radiotherapy.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
1 year post diagnosis
Yes
Te Vuong, MD
Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital
Canada: Health Canada
KIR 009
NCT01274962
November 2009
December 2020
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