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

NCT01274962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-06-26

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Principal Investigators

  • Te Vuong, MD · Sir Mortimer B. Davis - Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01274962 on ClinicalTrials.gov