At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed rectal adenocarcinoma
- ✓Radical resection clinically possible without distant metastases on imaging
- ✓Age 18 years or older at consent
- ✓ECOG PS 0-1 (PS 0 if aged ≥70 years)
- ✕Extensive surgery (excluding colostomy/central venous port) within 4 weeks before treatment
- ✕History of severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema)
- ✕Colonic stent in place
- ✕MRI contraindications (e.g., cardiac pacemakers)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Randomized Phase III Study of Short-term Radiotherapy Plus CAPOX and Short-term Radiotherapy Plus CAPOXIRI as Preoperative Treatment for Locally Advanced Rectal Cancer
In Brief
A Phase 3 clinical trial evaluating SCRT, CAPOX, and 1 other intervention for Locally Advanced Rectal Cancer. Currently recruiting, targeting 608 participants across 34 sites.
Signals
Detailed Summary
This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
Study Details
Timeline
Interventions
5x5 Gy: 25 Gy
Six cycles of CAPOX capecitabine 1000 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1, every 3 weeks
Six cycles of CAPOXIRI capecitabine 800 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1 and irinotecan 150 mg/m2 intravenously on day 1, every 3 weeks