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.

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