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Status:

UNKNOWN

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

Lead Sponsor:

Institute of Cancer Research, United Kingdom

Conditions:

Malignant Mesothelioma

Eligibility:

All Genders

18+ years

Phase:

NA

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 ch...

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 overa...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    670 Patients enrolled

    Trial Details

    Trial ID

    NCT00253409

    Start Date

    May 1 2005

    Last Update

    July 14 2009

    Active Locations (17)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (17 locations)

    1

    Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, United Kingdom, B15 2TH

    2

    Birmingham Heartlands Hospital

    Birmingham, England, United Kingdom, B9 5SS

    3

    Bristol Royal Infirmary

    Bristol, England, United Kingdom, BS2 8HW

    4

    Queen's Hospital

    Burton-on-Trent, England, United Kingdom, DE13 0RB