drugset / Trial / NCT03565029

Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer

NCT03565029 ↗

Phase 2 Completed 180 enrolled Niguarda Hospital
NaSingle-groupOpen-labelTreatment

Summary

NO-CUT is a one-stage phase II trial seeking to establish whether an oxaliplatin-based chemotherapy preceding standard neo-adjuvant fluoropyrimidines-based chemo radiotherapy, can safely spare demolitive surgical intervention in patients with operable rectal cancer, without increasing the risk of distant relapse. The trial also has a translational component aimed at establishing whether selected genomic, epigenetic, and transcriptomic markers are predictive of tumor and patient outcome.

Timeline

Start
2018-06-01
Primary completion
2022-10-31
Completion
2023-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — —
Subject Oxaliplatin Small molecule — —

Indications