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NCT06269978 · ClinicalTrials.gov registry record · Phase 1
Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer
A Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, sponsored by Arjun Mittra.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT06269978: Recruiting Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, sponsored by Arjun Mittra.
NCT06269978 is a Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8 that is actively recruiting participants, run by Arjun Mittra. The registered enrollment target is 24 participants, below the 88-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06269978, a Phase 1 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, is actively recruiting participants, sponsored by Arjun Mittra.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.
Primary Outcome
MTD will be determined based on isotonic regression. Specifically, the MTD will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the targeted dose limiting toxicities via Bayesian optimal interval software.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Fluorouracil
- PROCEDURE Diagnostic Laparoscopy
Study Locations (2)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Texas
- UT Southwestern/Simmons Cancer Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-12-31 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT06269978 shows while recruiting
NCT06269978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 88-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06269978 reports a single indexed study location in Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT06269978 about?
NCT06269978 is a clinical study titled "Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer". This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineopl...
What is the current status of trial NCT06269978?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-12-31. Estimated completion is 2026-09-30.
What conditions does trial NCT06269978 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Metastatic Malignant Neoplasm in the Peritoneum.
What interventions are being tested in trial NCT06269978?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Fluorouracil (DRUG), Diagnostic Laparoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT06269978?
This trial is sponsored by Arjun Mittra, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06269978 being conducted?
This trial has 2 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Colorectal Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06269978's enrollment target sits among peer trials
24 19th of 22 higher than 4 of 22 other Metastatic Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Carcinoma 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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