drugset / Trial / NCT06834126

Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial

NCT06834126

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of papaverine (PPV) when given together with radiation therapy (RT) and tests how well it works in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). PPV is an enzyme inhibitor, and it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving PPV with RT may be safe, tolerable, and/or effective in treating patients with locally advanced rectal cancer.

Timeline

Start
2025-04-07
Primary completion
2028-09-19
Completion
2028-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Papaverine Small molecule Intravenous

Indications