drugset / Trial / NCT05412082

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082

Phase 1 Recruiting 25 enrolled University of Miami
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and be spared from surgery.

Timeline

Start
2022-10-05
Primary completion
2026-10-31
Completion
2028-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 825 mg/m2 Oral
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 225 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

No indication recorded.