NCT03051464 No Surgery Trial / Two Dose-escalation Strategies
| 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 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound * Rectal cancer staged as N0 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
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