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Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

NCT00334594 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-05-15

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.

Conditions

  • Malignant Mesothelioma

Interventions

DRUG

Cisplatin

Cisplatin 75 mg/m2 i.v. over approximately 2 hours on day 1 every 21 days

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 every 21 days

PROCEDURE

Therapeutic conventional surgery

Extrapleural pneumonectomy

RADIATION

Radiotherapy

CTV1 will receive 45 or 46 Gy. CTV2 will be treated up to a total dose of 55,9 to 56,2 Gy.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Rolf A. Stahel, Prof · UniversitaetsSpital Zuerich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-14
Primary Completion
2014-03-26
Completion
2018-01-23

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00334594 on ClinicalTrials.gov