This trial is active, not recruiting.

Condition malignant mesothelioma
Treatments chemotherapy, adjuvant therapy, conventional surgery, neoadjuvant therapy, radiation therapy
Sponsor Institute of Cancer Research, United Kingdom
Start date May 2005
End date June 2011
Trial size 670 participants
Trial identifier NCT00253409, CDR0000448615, EU-20532, ICR-CTSU-MARS


RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without surgery and radiation therapy in treating mesothelioma.

PURPOSE: This randomized clinical trial is studying combination chemotherapy, surgery, and radiation therapy to see how well they work compared to combination chemotherapy alone in treating patients with mesothelioma that can be removed by surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically and immuno-histochemically confirmed malignant mesothelioma - Resectable disease (T1-3, N0-1, M0) with no distant metastases - Eligible to undergo extra-pleural pneumonectomy based on British Thoracic Society guidelines PATIENT CHARACTERISTICS: Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Normal renal function Cardiovascular - Ejection fraction ≥ 40% Pulmonary - Predicted post-operative FEV_1 ≥ 40% - Predicted post-operative DLCO ≥ 40% - No significant pulmonary hypertension Other - No physical or personal condition that would preclude ability to undergo chemotherapy or post-operative radiotherapy - No physical or personal condition that would preclude ability to comply with follow-up requirements PRIOR CONCURRENT THERAPY: - Not specified

Additional Information

Official title Mesothelioma and Radical Surgery Trial
Description OBJECTIVES: - Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma. - Compare the overall survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a multicenter, pilot study followed by a randomized, controlled study. Patients undergo 3 courses of a platinum-based (cisplatin or carboplatin) combination chemotherapy regimen to be determined by the treatment center. Upon completion of combination chemotherapy, patients are randomized to 1 of 2 treatment arms provided tumor is resectable and there is no disease progression. - Arm I: Patients undergo extra-pleural pneumonectomy followed by post-operative radiotherapy. - Arm II: Patients undergo follow-up only. Patients may receive additional standard therapy according to their treatment center. Quality of life is assessed at baseline, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 50-670 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).