Mesothelioma and Radical Surgery Trial
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Clare Peckitt
Study Chair
Institute of Cancer Research, United Kingdom
United States: Federal Government
CDR0000448615
NCT00253409
May 2005
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