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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00253409
First received: November 11, 2005
Last updated: July 11, 2009
Last verified: July 2009
  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.


Condition Intervention
Malignant Mesothelioma
Drug: chemotherapy
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Mesothelioma and Radical Surgery Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 670
Study Start Date: May 2005
Estimated Primary Completion Date: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253409

Locations
United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Queen's Hospital
Burton-upon-Trent, England, United Kingdom, DE13 0RB
Papworth Hospital
Cambridge, England, United Kingdom, CB3 8RE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Glenfield Hospital
Leicester, England, United Kingdom, LE3 9QP
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
St. Thomas' Hospital
London, England, United Kingdom, SE1 9RT
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5NG
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Study Chair: Clare Peckitt Institute of Cancer Research, United Kingdom
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00253409     History of Changes
Other Study ID Numbers: CDR0000448615, ICR-CTSU-MARS, EU-20532
Study First Received: November 11, 2005
Last Updated: July 11, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014