A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer

Official Title

An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer


This study is proposed to evaluate whether giving part of the chemotherapy prior to radiation therapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiation therapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.

Trial Description

Primary Outcome:

  • Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
Secondary Outcome:
  • Disease free survival rate (local recurrence and metastases)
  • Overall survival rate
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 radiation therapy.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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