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NCT00571298 · ClinicalTrials.gov registry record · Phase 1
Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
NCT00571298 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 141 participants.
The verdict
NCT00571298, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
Study Summary
RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is currently used safely as in intra-operative treatment for malignant pleural mesothelioma. This study is aimed to determine if the addition of gemcitabine as a second intracavitary chemotherapy can be accomplished safely. PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting of gemcitabine and cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees Celsius and the effect of cytoprotection agents: amifostine and sodium thiosulfate to counteract potential side effects of chemotherapy.
Interventions
- DRUG Cisplatin
- DRUG gemcitabine
- DRUG sodium thiosulfate
- PROCEDURE Extrapleural pneumonectomy (EPP)
- DRUG amifostine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2007-11 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00571298
The ClinicalTrials.gov registry entry for NCT00571298 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT00571298 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00571298 about?
NCT00571298 is a clinical study titled "Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma". RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is currently used safely as in intra-operative treatment for malignant pleural mesothelioma. This study is aimed to determin...
What is the current status of trial NCT00571298?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2007-11. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00571298?
The interventions under investigation include: Cisplatin (DRUG), gemcitabine (DRUG), sodium thiosulfate (DRUG), Extrapleural pneumonectomy (EPP) (PROCEDURE), amifostine (DRUG).
Who is sponsoring clinical trial NCT00571298?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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