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Patients in arm A will receive 6 cycles of FOLFOX chemotherapy prior to radiotherapy and surgery as well as 6 cycles of chemotherapy in adjuvant

Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery

* Oxaliplatin\* 85 mg/m2 IV in 500 mL of D5W over 120 minutes
* Folinic Acid (Leucovorin)\* 400 mg/m2 IV in 250 ml D5W over 120 minutes
* 5-Fluorouracil (5-FU) 400 mg/m2 IV bolus, after Folinic Acid
* 5-Fluorouracil\*\* 2400 mg/m2 IV over 46 h in D5W to a total volume of 92 mL by continuous infusion at 2 mL/hour.
* Repeat every 14 days for 6 cycles in the arm A and to be completed with 6 cycles after surgery and 12 cycles in arm B.

If necessary the schedule may be modified +/- 3 days.

FOLFOX

High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.

high dose rate endorectal brachytherapy

Te Vuong, MD

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

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.

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

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

Sanofi

Sir Mortimer B. Davis - Jewish General Hospital

Director Radiation Oncology Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer	NCT01274962	Operable T2-3N+...	FOLFOX high dose rate ...	18 Years -	Sir Mortimer B. Davis - Jewish General Hospital
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer	NCT01274962	Operable T2-3N+...	FOLFOX high dose rate ...	18 Years -	Sir Mortimer B. Davis - Jewish General Hospital

Spots Global Cancer Trial Database for high dose rate endorectal brachytherapy