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NCT02040142 · ClinicalTrials.gov registry record · Phase 2
HIPEC for Peritoneal Carcinomatosis
A Phase 2 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT02040142 is a Phase 2 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 51 participants.
The verdict
NCT02040142, a Phase 2 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a clinical study investigating the new treatment of surgery combined with intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved by the U.S. Food and Drug Administration (FDA)for many different cancers including gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA approved and is an investigation therapy. Cytoreductive surgery plus intraperitoneal chemotherapy can be offered as standard of care outside of a clinical trial. However, since this is an unproven and potentially more effective but a more toxic approach, the investigators are performing this procedure under an IRB approved clinical trial in order to better evaluate the risks and benefits of this approach. A standardized, evidence-based approach is currently lacking for patients with peritoneal surface malignancy from gastrointestinal origin. A clinical trial with surgical quality assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical assessment of disease burden, determinants of complete cytoreduction, treatment-related toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery is performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is used to treat microscopic residual disease with the objective of removing disease completely in a single procedure.
Interventions
- DRUG Mitomycin C
- PROCEDURE HIPEC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-11 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02040142
The ClinicalTrials.gov registry entry for NCT02040142 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mitomycin C is the first listed.
NCT02040142 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02040142 about?
NCT02040142 is a clinical study titled "HIPEC for Peritoneal Carcinomatosis". This is a clinical study investigating the new treatment of surgery combined with intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved by the U.S. Food and Drug Adminis...
What is the current status of trial NCT02040142?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2011-11. Estimated completion is 2024-08-19.
What interventions are being tested in trial NCT02040142?
The interventions under investigation include: Mitomycin C (DRUG), HIPEC (PROCEDURE).
Who is sponsoring clinical trial NCT02040142?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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