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ACTIVE NOT RECRUITING Phase 2

ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis

NCT01815359 · View on ClinicalTrials.gov ↗

Study Summary

This is the first randomized trial comparing Early post-operative intraperitoneal chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and colorectal cancer. The purpose of this study is to find out what effects, good and/or bad, EPIC and HIPEC after cytoreductive surgery have on the patient and the appendiceal, rectal or colon cancer.

Interventions

  • PROCEDURE Cytoreductive Surgery
  • DRUG HIPEC with Mitomycin-C
  • DRUG EPIC with FUDR and Leucovorin

Study Locations (9)

New York

  • Memorial Sloan Kettering Commack (Consent and Follow up) — Commack
  • Memorial Sloan Kettering Westchester (Consent and Follow up) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Consent and Follow up) — Uniondale

New Jersey

  • Memorial Sloan Kettering Basking Ridge (Consent and Follow up) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent and Follow up) — Middletown
  • Memorial Sloan Kettering Bergen (Consent and Follow up) — Montvale

Florida

  • University of Miami — Miami

Missouri

  • Washington University School of Medicine — St Louis

Trial Details

FieldValue
Enrollment Target 292 participants
Start Date 2013-03
Est. Completion 2026-09
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01815359

The ClinicalTrials.gov registry entry for NCT01815359 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which Cytoreductive Surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01815359 reports 9 study locations spanning 4 distinct geographic areas — top geographies include New York, New Jersey, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01815359 about?

NCT01815359 is a clinical study titled "ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis". This is the first randomized trial comparing Early post-operative intraperitoneal chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and colorectal cancer. The purpose of this study is to find out what effects, good and/or bad, EPIC and HIPEC after cytoreductiv...

What is the current status of trial NCT01815359?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 292 participants. The study started on 2013-03. Estimated completion is 2026-09.

What conditions does trial NCT01815359 study?

This clinical trial studies the following conditions: Colorectal Cancer, Appendix Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01815359?

The interventions under investigation include: Cytoreductive Surgery (PROCEDURE), HIPEC with Mitomycin-C (DRUG), EPIC with FUDR and Leucovorin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01815359?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01815359 being conducted?

This trial has 9 study locations across Florida, Missouri, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial