 |
|
Randomized Pilot Study of Neoadjuvant Combination Chemotherapy With Versus Without Surgery and Adjuvant Radiotherapy in Patients With Resectable Malignant Mesothelioma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
No phase specified
|
|
|
|
Treatment
|
|
|
|
Active
|
|
|
|
18 and over
|
|
|
|
Other
|
|
|
|
ICR-CTSU-MARS
EU-20532, NCT00253409
|
|
|
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.
Entry Criteria 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
Prior/Concurrent Therapy:
Patient Characteristics:
Performance status Life expectancy Hematopoietic Hepatic Renal Cardiovascular Pulmonary - Predicted post-operative FEV1 ≥ 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
Expected Enrollment 670A total of 50-670 patients will be accrued for this study. 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
Trial Contact Information
Trial Lead Organizations Institute of Cancer Research - Sutton | | | | Clare Peckitt, Protocol chair | | | |
Trial Sites
|
|
|
|
| United Kingdom |
|
| England |
|
| |
Birmingham |
|
| | | | | Birmingham Heartlands Hospital |
| | | Joyce Thompson | |
| | | Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust |
| | | A.D. Chetiyawardana, MD | |
| | Email:
shan.chetiyawardana@uhb.nhs.uk |
|
| |
Bristol |
|
| | | Bristol Royal Infirmary |
| | | Anthony Morgan | |
|
| |
Burton-upon-Trent |
|
| | | Queen's Hospital |
| | | Paul Beckett, MD | |
| | Email:
paul.beckett@burtonh-tr-wmids.nhs.uk |
|
| |
Cambridge |
|
| | | Addenbrooke's Hospital |
| | | Suzy Harden, MD | |
| | | Papworth Hospital |
| | | Andrew Ritchie, MD | |
|
| |
Ipswich |
|
| | | Ipswich Hospital |
| | | Mahadevan Venkateswaran, MD | |
|
| |
Leeds |
|
| | | Cookridge Hospital |
| | | Michael Snee, MD | |
| | Email:
michael.snee@leedsth.nhs |
|
| |
Leicester |
|
| | | Glenfield Hospital |
| | | Gillian Thomas, MD, FRCR | |
| | | Leicester Royal Infirmary |
| | | Gillian Thomas, MD, FRCR | |
| | Email:
gill.thomas@uhl-tr.nhs.uk |
|
| |
London |
|
| | | Royal Marsden - London |
| | | Mary O'Brien, MD | |
| | | St. Thomas' Hospital |
| | | David Landau | |
|
| |
Nottingham |
|
| | | Nottingham City Hospital NHS Trust |
| | | Sally Morgan, MD | |
|
| |
Reading |
|
| | | Berkshire Cancer Centre at Royal Berkshire Hospital |
| | | Paul Rogers, MD | |
|
| |
Sheffield |
|
| | | Cancer Research Centre at Weston Park Hospital |
| | | Matthew Hatton, MD | |
| | Email:
matthew.hatton@sth.nhs.uk |
|
| |
Sutton |
|
| | | Institute of Cancer Research - Sutton |
| | | Clare Peckitt | |
| | Email:
clare.peckitt@icr.ac.uk |
| | | Royal Marsden - Surrey |
| | | Mary O'Brien, MD | |
| | Email:
mary.o'brien@rmh.nhs.uk |
|
| Registry Information | | | Official Title | | Mesothelioma and Radical Surgery Trial | | | Trial Start Date | | 2005-05-01 | | | Trial Completion Date | | 2011-06-30 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00253409 | | | Date Submitted to PDQ | | 2005-09-01 | | | Information Last Verified | | 2008-12-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
