NCT03051464 Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
| NCT ID | NCT03051464 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital |
| Condition | Stage II Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 131 participants |
| Start Date | 2017-04-25 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 131 participants in total. It began in 2017-04-25 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound * Rectal cancer staged as N0-1 by MRI or EUS/TRUS * No metastatic lesion * Rectal tumor occupying less than half of the circumference * Tumor less than 5 cm on its largest dimension * Tumor located at less than 10 cm from the anal verge * Tumor penetration less than 5 mm in the mesorectal fat * Tumor accessible for brachytherapy * Lumen accessible for colonoscopy * Patient should be a suitable candidate for brachytherapy and chemotherapy * Older than 18 years of age * Adequate birth control measures in women of childbearing potential * Written informed consent Exclusion Criteria: * Patients with previous pelvic radiation * Evidence of distant metastasis * Extension of malignant disease to the anal canal * Tumors staged as T4 * Tumors larger than 5 cm in length
Contact & Investigator
Te Vuong, MD
PRINCIPAL INVESTIGATOR
Sir Mortimer Jewish General Hospital
Frequently Asked Questions
Who can join the NCT03051464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stage II Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03051464 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03051464 currently recruiting?
Yes, NCT03051464 is actively recruiting participants. Contact the research team at sknoepfel@jgh.mcgill.ca for enrollment information.
Where is the NCT03051464 trial being conducted?
This trial is being conducted at Dallas, United States, Montreal, Canada, Montreal, Canada, Québec, Canada.
Who is sponsoring the NCT03051464 clinical trial?
NCT03051464 is sponsored by Sir Mortimer B. Davis - Jewish General Hospital. The principal investigator is Te Vuong, MD at Sir Mortimer Jewish General Hospital. The trial plans to enroll 131 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.