Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 and over	Other	ICR-CTSU-MARS EU-20532, NCT00253409

Objectives

1. Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma.
2. Compare the overall survival of patients treated with these regimens.
3. Compare the quality of life of patients treated with these regimens.

Entry Criteria

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

Prior/Concurrent Therapy:

• Not specified

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 FEV₁ ≥ 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

Expected Enrollment

A total of 50-670 patients will be accrued for this study.

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

Trial Contact Information

Trial Lead Organizations

Institute of Cancer Research - Sutton

Clare Peckitt, Protocol chair		Ph: 44-20-8722-4057 Email: clare.peckitt@icr.ac.uk

Registry Information
Official Title		Mesothelioma and Radical Surgery Trial
Trial Start Date		2005-05-01
Trial Completion Date		2011-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00253409
Date Submitted to PDQ		2005-09-01
Information Last Verified		2009-07-05

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