At a glance
ClinicalIndex Comparison Record- ✓Biopsy proven rectal adenocarcinoma
- ✓Tumor distance ≤10cm from anal verge
- ✓Locally advanced disease (AJCC T3, T4 or N+)
- ✓MRF+ or T4b on pelvic MRI
- ✕Distant metastases
- ✕Recurrent rectal cancer
- ✕Active Crohn's disease or ulcerative colitis
- ✕Concomitant malignancies (except basal cell carcinoma or in-situ cervical carcinoma)
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NCT03714490Phase 2RecruitingUpdate OverdueUpdated 25mo ago · Completion was 21mo agoMRI Simulation-guided Boost in Short-course Preoperative Radiotherapy (SCPRT) Followed by Consolidation Chemotherapy Versus Long Course Chemoradiation for Unresectable Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating SCPRT, CRT, and 1 other intervention for Rectal Neoplasms. Currently recruiting, targeting 200 participants across 1 site.
Signals
Detailed Summary
Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.
Study Details
Timeline
Interventions
Short-course preoperative radiotherapy(SCPRT), which consists of 5 Gy x 5f and 4Gy for boost on the GTV with MRI-simulation alone.
Long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively.
Patients will receive consolidation chemotherapy after 7-10 days of SCPRT completed, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are scheduled before surgery.