Malignant Mesothelioma Clinical Trial
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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