Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery (NCT03051464)
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
🩺 Plain-English Summary (8th-Grade Level)
A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 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).
Who can join: Review the eligibility criteria below.
Location: UT Southwestern Medical Center — Dallas, Texas
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
- Complete responders and Non-complete responders (PROCEDURE)
- Chemoradiation + EBRT Boost (RADIATION)
- Chemoradiation + HDRBT Boost (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- UT Southwestern Medical Center — Dallas, Texas
- Le Centre Hospitalier de l'Université de Montreal — Montreal, Quebec
- Jewish General Hospital — Montreal, Quebec
- Centre hospitalier universitaire de Québec — Québec, Quebec
📞 Contact the Study Coordinator
Phone: (514) 340-8288
Email: sknoepfel@jgh.mcgill.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Stage II Rectal Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.