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Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers
NCT03604653 · View on ClinicalTrials.gov ↗
Study Summary
Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach, colorectal, appendiceal, and gynecological primary origin will be screened by pathology and staging to see if they are eligible to undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). To be eligible for the study, patients must be over 18 years of age, have appropriate pathology and stage with disease confined to the peritoneal cavity, have a good performance status, have laboratory values that fall within safe ranges to undergo an operation and receive intraperitoneal chemotherapy. The chemotherapeutic agent and dose will be assigned based on pathological diagnosis in accordance with current standard of care. Surgery will be performed with the goal of removing all visible tumor that may require removal of adjacent organs. Once only microscopic disease is present, the chemotherapy will be delivered directly into the peritoneum via intraperitoneal hyperthermia and perfusion device. This will continue for 90 minutes. Patients will be followed for tumor response, survival, toxicity, complications, quality of life, and tumor markers. They will have regular follow up visits with the surgeon, undergo routine surveillance imagings, and receive follow up phone calls periodically.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Mitomycin c
- DEVICE HIPEC
- DRUG CDDP 50
- DRUG CDDP 75
Study Locations (1)
New Jersey
- Holy Name Medical Center — Teaneck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2021-05-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03604653
The ClinicalTrials.gov registry entry for NCT03604653 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Holy Name Medical Center, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which Doxorubicin 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: NCT03604653 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. 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 NCT03604653 about?
NCT03604653 is a clinical study titled "Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers". Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach, colorectal, appendiceal, and gynecological primary origin will be screened by pathology and staging to see if they are eligible to undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemothera...
What is the current status of trial NCT03604653?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2018-05-15. Estimated completion is 2021-05-01.
What conditions does trial NCT03604653 study?
This clinical trial studies the following conditions: Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Fallopian Tube Cancer, Uterine 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 NCT03604653?
The interventions under investigation include: Doxorubicin (DRUG), Mitomycin c (DRUG), HIPEC (DEVICE), CDDP 50 (DRUG), CDDP 75 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03604653?
This trial is sponsored by Holy Name Medical Center, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03604653 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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