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NCT06834126 · ClinicalTrials.gov registry record · Phase 1
Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial
A Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06834126: Recruiting Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT06834126 is a Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 36 participants, below the 114-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06834126, a Phase 1 study of Stage III Rectal Cancer AJCC v8 and Stage II Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. A defined adverse event considered to be possibly, probably, or definitely related to study treatment (radiation therapy or PPV). Will employ the time-to-event Bayesian optimal interval design (TITE-BOIN) to find the maximum tolerated dose (MTD).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Gastrointestinal Endoscopy
- DRUG Consolidation Therapy
- PROCEDURE Functional Magnetic Resonance Imaging
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2028-09-19 |
| Phase | Phase 1 |
What NCT06834126 shows while recruiting
NCT06834126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 114-participant average among 15 other Stage III Rectal Cancer AJCC v8 trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Stage III Rectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06834126 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06834126 about?
NCT06834126 is a clinical study titled "Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial". 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...
What is the current status of trial NCT06834126?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-04-07. Estimated completion is 2028-09-19.
What conditions does trial NCT06834126 study?
This clinical trial studies the following conditions: Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Locally Advanced Rectal Adenocarcinoma.
What interventions are being tested in trial NCT06834126?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Gastrointestinal Endoscopy (PROCEDURE), Consolidation Therapy (DRUG), Functional Magnetic Resonance Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT06834126?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06834126 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06834126's enrollment target sits among peer trials
36 10th of 15 higher than 6 of 15 other Stage III Rectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Rectal Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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