Official Title: “Mesothelioma and Radical Surgery Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

Study Primary Completion Date: June 2011

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.

Intervention(s) in this Clinical Trial

• Drug: chemotherapy
• Procedure: adjuvant therapy
• Procedure: conventional surgery
• Procedure: neoadjuvant therapy
• Radiation: radiation therapy

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Institute of Cancer Research, United Kingdom

Overall Clinical Trial Officials and Contacts

Clare Peckitt Study Chair Institute of Cancer Research, United Kingdom  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00253409

Study ID Number: CDR0000448615

ClinicalTrials.gov Identifier: NCT00253409

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database