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Mesothelioma Related Clinical Trials:
Mesothelioma and Radical Surgery Trial
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Recruiting
Sponsors and Collaborators: Institute of Cancer Research, United Kingdom
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00253409
Condition: Malignant Mesothelioma
Intervention: Procedure: adjuvant therapy; Procedure: chemotherapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Procedure: radiation therapy
Purpose:
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.
| Study Type: Â | Interventional |
| Study Design: Â | Treatment, Randomized, Active Control |
| Official Title: Â | Mesothelioma and Radical Surgery Trial |
| Estimated Enrollment: Â | 670 |
| Study Start Date: Â | May 2005 |
| Estimated Primary Completion Date: Â | June 2011 (Final data collection date for primary outcome measure) |
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 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.
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253409Locations
| United Kingdom, England | |||||
| Addenbrooke's Hospital   | Recruiting | ||||
| Â Â Â Cambridge, England, United Kingdom, CB2 2QQ | |||||
| Â Â Â Contact: Suzy Harden, MD Â Â 44-1223-245-151 Â Â Â Â | |||||
| Berkshire Cancer Centre at Royal Berkshire Hospital   | Recruiting | ||||
| Â Â Â Reading, England, United Kingdom, RG1 5AN | |||||
| Â Â Â Contact: Paul Rogers, MD Â Â 44-118-987-7688 Â Â Â Â | |||||
| Birmingham Heartlands Hospital   | Recruiting | ||||
| Â Â Â Birmingham, England, United Kingdom, B9 5SS | |||||
|    Contact: Joyce Thompson   44-121-766-6611     | |||||
| Bristol Royal Infirmary   | Recruiting | ||||
| Â Â Â Bristol, England, United Kingdom, BS2 8HW | |||||
|    Contact: Anthony Morgan   44-117-923-0000     | |||||
| Cancer Research Centre at Weston Park Hospital   | Recruiting | ||||
| Â Â Â Sheffield, England, United Kingdom, S1O 2SJ | |||||
|    Contact: Matthew Hatton, MD   44-114-226-5080   matthew.hatton@sth.nhs.uk   | |||||
| Cookridge Hospital   | Recruiting | ||||
| Â Â Â Leeds, England, United Kingdom, LS16 6QB | |||||
|    Contact: Michael Snee, MD   44-113-392-4347   michael.snee@leedsth.nhs   | |||||
| Glenfield Hospital   | Recruiting | ||||
| Â Â Â Leicester, England, United Kingdom, LE3 9QP | |||||
| Â Â Â Contact: G. D. Thomas, MD, FRCR Â Â 44-116-287-1471 Â Â Â Â | |||||
| Institute of Cancer Research - Sutton   | Recruiting | ||||
| Â Â Â Sutton, England, United Kingdom, SM2 5NG | |||||
|    Contact: Clare Peckitt   44-20-8722-4057   clare.peckitt@icr.ac.uk   | |||||
| St. Thomas' Hospital   | Recruiting | ||||
| Â Â Â London, England, United Kingdom, SE1 9RT | |||||
|    Contact: David Landau   44-20-7955-5000     | |||||
| Nottingham City Hospital NHS Trust   | Recruiting | ||||
| Â Â Â Ipswich, England, United Kingdom, IP4 5PD | |||||
|    Contact: Contact Person   44-1473-712-233     | |||||
| Papworth Hospital   | Recruiting | ||||
| Â Â Â Cambridge, England, United Kingdom, CB3 8RE | |||||
| Â Â Â Contact: Andrew Ritchie, MD Â Â 44-1480-830-541 Â Â Â Â | |||||
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust   | Recruiting | ||||
| Â Â Â Birmingham, England, United Kingdom, B15 2TH | |||||
|    Contact: A.D. Chetiyawardana, MD   44-121-472-1311   shan.chetiyawardana@uhb.nhs.uk   | |||||
| Queen's Hospital   | Recruiting | ||||
| Â Â Â Burton-upon-Trent, England, United Kingdom, DE13 0RB | |||||
|    Contact: Paul Beckett, MD   44-1283-566-333   paul.beckett@burtonh-tr-wmids.nhs.uk   | |||||
| Royal Marsden NHS Foundation Trust - London   | Recruiting | ||||
| Â Â Â London, England, United Kingdom, SW3 6JJ | |||||
| Â Â Â Contact: Mary O'Brien, MD Â Â 44-20-7352-8171 Â Â Â Â | |||||
| Royal Marsden NHS Foundation Trust - Surrey   | Recruiting | ||||
| Â Â Â Sutton, England, United Kingdom, SM2 5PT | |||||
|    Contact: Mary O'Brien, MD   44-20-8661-3276   mary.o'brien@rmh.nhs.uk   | |||||
| Ipswich Hospital   | Recruiting | ||||
| Â Â Â Ipswich, England, United Kingdom, IP4 5PD | |||||
| Â Â Â Contact: Mahadevan Venkateswaran, MD Â Â 44-1473-712-233 Â Â Â Â | |||||
Sponsors and Collaborators
| Institute of Cancer Research, United Kingdom |
Investigators
| Study Chair:   | Clare Peckitt   | Institute of Cancer Research, United Kingdom   |
Additional Information:
| Study ID Numbers: Â | CDR0000448615, ICR-CTSU-MARS, EU-20532 |
| First Received: Â | November 11, 2005 |
| Last Updated: Â | February 6, 2008 |
| ClinicalTrials.gov Identifier: Â | NCT00253409 |
| Health Authority: Â | Unspecified |
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