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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334594 |
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.
Condition | Intervention | Phase |
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Malignant Mesothelioma |
Drug: cisplatin Drug: pemetrexed disodium Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial |
Estimated Enrollment: | 155 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, histology (sarcomatous or other vs epithelial or mixed histology), nodal status (N0-1 vs N2), and extent of disease (T1-2 vs T3).
Part 2 : Patients achieving R0 or R1 resection proceed to part 2 of study treatment and are randomized to 1 of 2 treatment arms. Patients with R2 resection, disease progression, or symptomatic deterioration after treatment in part 1 are taken off study.
After completion of study treatment, patients are followed periodically for up to 5 years after surgery.
PROJECTED ACCRUAL: A total of 155 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma
No obvious widespread chest wall invasion
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Switzerland | |
UniversitaetsSpital Zuerich | Recruiting |
Zurich, Switzerland, CH-8091 | |
Contact: Rolf A. Stahel, MD 41-1-634-2871 rolf.stahel@usz.ch |
Study Chair: | Rolf A. Stahel, MD | UniversitaetsSpital Zuerich |
Study ID Numbers: | CDR0000481153, SWS-SAKK-17/04, EU-20615, EUDRACT-2006-000445-19, LILLY-SAKK-17/04 |
Study First Received: | June 7, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00334594 History of Changes |
Health Authority: | Unspecified |
advanced malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma localized malignant mesothelioma |
Antimetabolites Folic Acid Pemetrexed Radiation-Sensitizing Agents Cisplatin |
Adjuvants, Immunologic Mesothelioma Folic Acid Antagonists Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Pemetrexed Neoplasms Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |