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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

November 11, 2005
July 11, 2009
May 2005
June 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00253409 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
Mesothelioma and Radical Surgery Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Treatment
Malignant Mesothelioma
  • Drug: chemotherapy
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
670
Not Provided
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00253409
CDR0000448615, ICR-CTSU-MARS, EU-20532
Not Provided
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Institute of Cancer Research, United Kingdom
Not Provided
Study Chair: Clare Peckitt Institute of Cancer Research, United Kingdom
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP