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Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

NCT00165503 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-09-09

Study results available
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Summary

The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.

Conditions

  • Pleural Mesothelioma
  • Malignant Pleural Mesothelioma

Interventions

DRUG

Cisplatin

DRUG

Sodium Thiosulfate

DRUG

ALIMTA

Sponsors & Collaborators

Principal Investigators

  • David J. Sugarbaker, MD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00165503 on ClinicalTrials.gov