NCT01274962

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Operable T2-3N+M0 Rectal Cancer (Stage III)

Interventions

Type	Name	Description
DRUG	FOLFOX	* 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.
RADIATION	high dose rate endorectal brachytherapy	High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.

Timeline

• Start date: 2009-11-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2011-01-12
• Last updated: 2024-06-26

Locations

8 sites across 1 country: Canada