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Anti-metabolites

high dose rate endorectal brachytherapy for Rectal Cancer

Phase 2
Waitlist Available
Led By Te Vuong, MD
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post surgery
Awards & highlights

Study Summary

This trial will study whether giving chemotherapy before surgery, instead of after, will help patients with rectal cancer comply better with their treatment plan.

Eligible Conditions
  • Rectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
Secondary outcome measures
Disease free survival rate (local recurrence and metastases)
Overall survival rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B - adjuvant chemotherapyExperimental Treatment2 Interventions
Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery
Group II: A - neoadjuvant chemotherapyExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFOX
2009
Completed Phase 3
~4560
high dose rate endorectal brachytherapy
2009
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
20,980 Total Patients Enrolled
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,800 Total Patients Enrolled
Te Vuong, MDPrincipal InvestigatorSir Mortimer B. Davis - Jewish General Hospital
6 Previous Clinical Trials
257 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still enrolling people in this clinical trial?

"Unfortunately, this study is not actively looking for patients at the moment. However, it's worth mentioning that 321 other trials are currently enrolling participants."

Answered by AI

In how many different locations is this research study being conducted?

"This trial has 8 active locations, which include Centre Hospitalier Pierre-Boucher in Longueuil, CHUM-Hôpital St-Luc in Montréal, and Sir Mortimer B. Davis - Jewish General Hospital in Montreal."

Answered by AI

Could you please tell us about the long-term effects of high dose rate endorectal brachytherapy?

"Although high dose rate endorectal brachytherapy has not been proven effective yet, Phase 2 clinical trials have shown that it is safe."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer
Dr. Te Vuong 2009. "A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01274962.
~12 spots leftby Apr 2025
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