Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery

Malignant Mesothelioma Clinical Trial

Official title:

Mesothelioma and Radical Surgery Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00253409
• Other study ID #: CDR0000448615
• Secondary ID: ICR-CTSU-MARSEU-
• Status: Active, not recruiting
• Phase: N/A
• First received: November 11, 2005
• Last updated: July 11, 2009
• Start date: May 2005

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 670
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

Drug:
• chemotherapy

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England
United Kingdom	Bristol Royal Infirmary	Bristol	England
United Kingdom	Queen's Hospital	Burton-upon-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	Glenfield Hospital	Leicester	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	St. Thomas' Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom,