Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
NCT ID: NCT00253409
Last Updated: 2009-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
670 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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chemotherapy
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
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Clare Peckitt
Role: STUDY_CHAIR
Institute of Cancer Research, United Kingdom
Locations
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Papworth Hospital
Cambridge, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Glenfield Hospital
Leicester, England, United Kingdom
St. Thomas' Hospital
London, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Countries
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Other Identifiers
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ICR-CTSU-MARS
Identifier Type: -
Identifier Source: secondary_id
EU-20532
Identifier Type: -
Identifier Source: secondary_id
CDR0000448615
Identifier Type: -
Identifier Source: org_study_id
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