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NCT01580410 · ClinicalTrials.gov registry record · Phase 2
Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix
A Phase 2 study of Primary Peritoneal Cavity Cancer and Carcinoma of the Appendix, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
- 3
- Study locations
NCT01580410 is a Phase 2 study of Primary Peritoneal Cavity Cancer and Carcinoma of the Appendix that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 136 participants, above the 95-participant average among 15 other Primary Peritoneal Cavity Cancer trials with a reported enrollment target (43% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT01580410, a Phase 2 study of Primary Peritoneal Cavity Cancer and Carcinoma of the Appendix, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
- 3
- Study locations
Study Summary
This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Conditions Studied
Interventions
- DRUG oxaliplatin
- PROCEDURE therapeutic conventional surgery
- OTHER quality-of-life assessment
- DRUG mitomycin C
- DRUG hyperthermic intraperitoneal chemotherapy
Study Locations (3)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2009-05 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01580410
The ClinicalTrials.gov registry entry for NCT01580410 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 95-participant average among 15 other Primary Peritoneal Cavity Cancer trials with a reported enrollment target (43% higher). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Primary Peritoneal Cavity Cancer appearing as the primary indexed condition, and to 5 interventions - of which oxaliplatin is the first listed.
NCT01580410 reports 3 study locations spanning 3 distinct geographic areas - top geographies include North Carolina, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT01580410 about?
NCT01580410 is a clinical study titled "Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix". This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop t...
What is the current status of trial NCT01580410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2009-05. Estimated completion is 2016-11.
What conditions does trial NCT01580410 study?
This clinical trial studies the following conditions: Primary Peritoneal Cavity Cancer, Carcinoma of the Appendix.
What interventions are being tested in trial NCT01580410?
The interventions under investigation include: oxaliplatin (DRUG), therapeutic conventional surgery (PROCEDURE), quality-of-life assessment (OTHER), mitomycin C (DRUG), hyperthermic intraperitoneal chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01580410?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01580410 being conducted?
This trial has 3 study locations across North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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