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COMPLETED Phase 2

Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix

NCT01580410 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 136 participants
Start Date 2009-05
Est. Completion 2016-11
Phase Phase 2

Sponsor

Wake Forest University Health Sciences

1,061 total trials

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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. 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 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 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 Primary Peritoneal Cavity Cancer appearing as the primary indexed condition, and to 5 interventions — of which oxaliplatin 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: NCT01580410 reports 3 study locations spanning 3 distinct geographic areas — top geographies include North Carolina, Pennsylvania, Texas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01580410?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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