NCT01274962

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

13.1 years

First QC Date

January 11, 2011

Last Update Submit

June 25, 2024

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Disease free survival rate (local recurrence and metastases)

    5 years post surgery

  • Overall survival rate

    5 years post surgery

Study Arms (2)

A - neoadjuvant chemotherapy

EXPERIMENTAL

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

Drug: FOLFOXRadiation: high dose rate endorectal brachytherapy

Arm B - adjuvant chemotherapy

EXPERIMENTAL

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

Drug: FOLFOXRadiation: high dose rate endorectal brachytherapy

Interventions

FOLFOXDRUG

* 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.

A - neoadjuvant chemotherapyArm B - adjuvant chemotherapy
high dose rate endorectal brachytherapyRADIATION

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

A - neoadjuvant chemotherapyArm B - adjuvant chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathology: Adenocarcinoma of the rectum.
  • T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria)
  • Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any EMVI+ tumor
  • Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary mould applicator (e.g. non obstructive tumor).
  • Tumour of less than 3.5 cm thickness documented at the CT Simulator.
  • Patient should be a suitable candidate for surgery and chemotherapy.
  • WHO performance status 0-2
  • Age \> 18 years.
  • Written informed consent.
  • Adequate birth control measures in women with childbearing potential.

You may not qualify if:

  • Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral).
  • Evidence of distant metastases (M1).
  • Previous pelvic radiation.
  • Other cancers except for basal cell carcinoma of the skin or CIS of the cervix.
  • Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
  • Extension of malignant disease to the anal canal
  • Patients with severe co-morbid conditions (recent MI, infections, AIDS, etc)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hôpital de Gatineau

Gatineau, Quebec, J8T 8R2, Canada

Location

Hôpital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre Hospitalier Pierre-Boucher

Longueuil, Quebec, J4M 2A5, Canada

Location

CHUM-Hôpital St-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hôpital Honoré-Mercier

Saint-Hyacinthe, Quebec, J2S 4Y8, Canada

Location

Hôpital du Suroît

Salaberry-de-Valleyfield, Quebec, J6T 6C1, Canada

Location

CHUQ - Hôtel-Dieu de Québec

Québec, G1R 2J6, Canada

Location

MeSH Terms

Interventions

Folfox protocol

Study Officials

  • Te Vuong, MD

    Sir Mortimer B. Davis - Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Radiation Oncology Department

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 12, 2011

Study Start

November 1, 2009

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations

CA(8)