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

NCT06834126 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Adenocarcinoma
  • Stage II Rectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Consolidation Therapy

Receive CC with mFOLFOX6 or CAPOX

PROCEDURE

Functional Magnetic Resonance Imaging

Undergo fMRI

PROCEDURE

Gastrointestinal Endoscopy

Undergo endoscopy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Papaverine

Given IV

RADIATION

Radiation Therapy

Undergo RT

PROCEDURE

Total Mesorectal Excision

Undergo ToME

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Terence M Williams · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2028-09-19
Completion
2028-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06834126 on ClinicalTrials.gov