Phase 1 Study of Papaverine with Radiation Therapy to Treat Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating papaverine PPV combined with radiation therapy RT for patients with locally advanced rectal cancer that has spread to nearby tissue or lymph nodes. This phase I trial aims to find the best dose of PPV with RT, study its side effects, and see how well this combination works. PPV may block enzymes needed for tumor growth, and RT uses high-energy rays to kill tumor cells and shrink tumors. The study includes two groups one receives radiation therapy daily for one week followed by standard chemotherapy starting week 5, with possible surgery if the disease persists or returns. The other group gets PPV intravenously before and during radiation therapy, then the same chemotherapy and possible surgery. Patients undergo imaging tests like functional MRI, CT, MRI scans, endoscopy, and have blood and tissue samples collected during the trial. Participants will be followed every three months for two years after treatment, then every six months for three more years. Researchers will monitor side effects, safety, tumor response, survival rates, tumor oxygen levels, immune changes, and molecular markers. The study tracks acute and late toxicities, tumor control, disease-free survival, and overall survival to understand the effects of combining PPV with radiation therapy.

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