Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00253409|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 15, 2005
Last Update Posted : July 14, 2009
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.
|Condition or disease||Intervention/treatment|
|Malignant Mesothelioma||Drug: chemotherapy Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||670 participants|
|Official Title:||Mesothelioma and Radical Surgery Trial|
|Study Start Date :||May 2005|
|Estimated Primary Completion Date :||June 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253409
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2TH|
|Birmingham Heartlands Hospital|
|Birmingham, England, United Kingdom, B9 5SS|
|Bristol Royal Infirmary|
|Bristol, England, United Kingdom, BS2 8HW|
|Burton-upon-Trent, England, United Kingdom, DE13 0RB|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Cambridge, England, United Kingdom, CB3 8RE|
|Ipswich, England, United Kingdom, IP4 5PD|
|Leeds, England, United Kingdom, LS16 6QB|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Leicester, England, United Kingdom, LE3 9QP|
|St. Thomas' Hospital|
|London, England, United Kingdom, SE1 9RT|
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Berkshire Cancer Centre at Royal Berkshire Hospital|
|Reading, England, United Kingdom, RG1 5AN|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Institute of Cancer Research - Sutton|
|Sutton, England, United Kingdom, SM2 5NG|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Clare Peckitt||Institute of Cancer Research, United Kingdom|