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Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2026 → Sep 30, 2027
Enrollment reduced 62% 24 → 9 participants
See other at-risk trials from Arjun Mittra

Record History

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2027 Eligibility criteria expanded, about 34 words · Secondary endpoints: details revised at 5 of 5 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site details revised at 1 of 2 sites
  2. Enrollment reduced: 24 → 9 participants Enrollment closed, study ongoing · Site details revised at 2 of 2 sitesv8 Show 2 more changesShow less
    • Enrollment closed, study ongoing
    • Site details revised at 2 of 2 sites
  3. Primary and study completion dates: Jan 31, 2026 to Sep 30, 2026v7
  4. Study sites: 1 to 2 Eligibility criteria shortened, about 43 wordsv6 Show 1 more changeShow less
    • Eligibility criteria shortened, about 43 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date changed from estimate of Jan 31, 2025 to Dec 31, 2024 Site contact updatedv5 Show 1 more changeShow less
    • Site contact updated
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jun 30, 2024 to Jan 31, 2025 Primary and study completion dates: Dec 31, 2025 to Jan 31, 2026 · Eligibility criteria expanded, about 29 wordsv4 Show 2 more changesShow less
    • Primary and study completion dates: Dec 31, 2025 to Jan 31, 2026
    • Eligibility criteria expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Apr 30, 2024 to Jun 30, 2024v3
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 1, 2024 to Apr 30, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Mar 1, 2024 to Apr 30, 2024
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06269978
Lead Sponsor Arjun Mittra
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Colorectal Cancer AJCC v8
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov