Status:
UNKNOWN
Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ch...
Detailed Description
OBJECTIVES: * Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma. * Compare the overa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically and immuno-histochemically confirmed malignant mesothelioma
- Resectable disease (T1-3, N0-1, M0) with no distant metastases
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT00253409
Start Date
May 1 2005
Last Update
July 14 2009
Active Locations (17)
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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-on-Trent, England, United Kingdom, DE13 0RB