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Trial record 71 of 418 for:    mesothelioma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253409
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2005
Last Update Posted : July 14, 2009
Information provided by:
National Cancer Institute (NCI)

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 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 or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: chemotherapy Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Mesothelioma and Radical Surgery Trial
Study Start Date : May 2005
Estimated Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Normal renal function


  • Ejection fraction ≥ 40%


  • Predicted post-operative FEV_1 ≥ 40%
  • Predicted post-operative DLCO ≥ 40%
  • No significant pulmonary hypertension


  • 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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253409

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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
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Papworth Hospital
Cambridge, England, United Kingdom, CB3 8RE
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
St. Thomas' Hospital
London, England, United Kingdom, SE1 9RT
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
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
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5NG
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
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Study Chair: Clare Peckitt Institute of Cancer Research, United Kingdom

Layout table for additonal information Identifier: NCT00253409     History of Changes
Other Study ID Numbers: CDR0000448615
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

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

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