RecruitingPhase 2Phase 3NCT03051464

No Surgery Trial / Two Dose-escalation Strategies

A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer


Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrollment

131 participants

Start Date

Apr 25, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial explores whether some patients with early-stage rectal cancer can avoid surgery altogether by using a combination of internal radiation (brachytherapy) and chemotherapy, comparing two different radiation dosing strategies. **You may be eligible if...** - You are 18 or older with rectal cancer that has been staged as T2 or T3 (cancer that has grown into but not completely through the rectal wall) based on MRI or ultrasound - Your cancer has not spread to lymph nodes or other organs - Your tumor is small (less than 5 cm), located in the lower rectum (within 10 cm of the anal opening), and accessible for internal radiation treatment - You are a good candidate for both brachytherapy (internal radiation) and chemotherapy **You may NOT be eligible if...** - You have previously had radiation to the pelvic area - Your cancer has spread to other parts of the body (metastatic disease) - The cancer extends into the anal canal - Your tumor is classified as T4 (deeply invasive) or is larger than 5 cm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComplete responders and Non-complete responders

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

RADIATIONChemoradiation + EBRT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

RADIATIONChemoradiation + HDRBT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions


Locations(4)

UT Southwestern Medical Center

Dallas, Texas, United States

Le Centre Hospitalier de l'Université de Montreal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre hospitalier universitaire de Québec

Québec, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT03051464