drugset / Trial / NCT01952951

Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer

NCT01952951 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.

Timeline

Start
2014-06
Primary completion
2017-09
Completion
2019-12

Outcome

Missed primary endpoint

paper In arms A and B, downstaging was achieved in 21.2% and 36.4% (P = .077), respectively PMID 29976501 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 850 mg/m2 —
Subject Oxaliplatin Small molecule 100 mg/m2 —