Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
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Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma.
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Compare the overall survival of patients treated with these regimens.
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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.
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Arm I: Patients undergo extra-pleural pneumonectomy followed by post-operative radiotherapy.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically and immuno-histochemically confirmed malignant mesothelioma
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Resectable disease (T1-3, N0-1, M0) with no distant metastases
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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
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Predicted post-operative FEV_1 ≥ 40%
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Predicted post-operative DLCO ≥ 40%
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No significant pulmonary hypertension
Other
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No physical or personal condition that would preclude ability to undergo chemotherapy or post-operative radiotherapy
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No physical or personal condition that would preclude ability to comply with follow-up requirements
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Birmingham | England | United Kingdom | B15 2TH |
| 2 | Birmingham Heartlands Hospital | Birmingham | England | United Kingdom | B9 5SS |
| 3 | Bristol Royal Infirmary | Bristol | England | United Kingdom | BS2 8HW |
| 4 | Queen's Hospital | Burton-upon-Trent | England | United Kingdom | DE13 0RB |
| 5 | Addenbrooke's Hospital | Cambridge | England | United Kingdom | CB2 2QQ |
| 6 | Papworth Hospital | Cambridge | England | United Kingdom | CB3 8RE |
| 7 | Ipswich Hospital | Ipswich | England | United Kingdom | IP4 5PD |
| 8 | Cookridge Hospital | Leeds | England | United Kingdom | LS16 6QB |
| 9 | Leicester Royal Infirmary | Leicester | England | United Kingdom | LE1 5WW |
| 10 | Glenfield Hospital | Leicester | England | United Kingdom | LE3 9QP |
| 11 | St. Thomas' Hospital | London | England | United Kingdom | SE1 9RT |
| 12 | Royal Marsden - London | London | England | United Kingdom | SW3 6JJ |
| 13 | Nottingham City Hospital NHS Trust | Nottingham | England | United Kingdom | NG5 1PB |
| 14 | Berkshire Cancer Centre at Royal Berkshire Hospital | Reading | England | United Kingdom | RG1 5AN |
| 15 | Cancer Research Centre at Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 16 | Institute of Cancer Research - Sutton | Sutton | England | United Kingdom | SM2 5NG |
| 17 | Royal Marsden - Surrey | Sutton | England | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Institute of Cancer Research, United Kingdom
Investigators
- Study Chair: Clare Peckitt, Institute of Cancer Research, United Kingdom
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000448615
- ICR-CTSU-MARS
- EU-20532