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Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung

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: NCT00030745
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have mesothelioma of the lung.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: conventional surgery Phase 2

Detailed Description:


  • Determine the proportion of patients with potentially resectable mesothelioma of the pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine.
  • Determine the response rate and overall survival of patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Determine the number of postoperative hospitalization days and occurrence and duration of surgical complications in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.
  • Compare the proportion of patients who report psychological distress at 3 months after surgery vs at study registration.

OUTLINE: Patients receive cisplatin IV on day 1 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses. Within 6 weeks after completion of chemotherapy, patients undergo restaging by CT scan followed by surgical resection.

Quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery, and then at 3 and 6 months.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
Study Start Date : June 2000
Actual Primary Completion Date : May 2003
Actual Study Completion Date : August 2003

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 clinically confirmed pleural mesothelioma

    • Stages T1-3, N0-2, M0 by CT scan of the chest

      • Mediastinoscopy required for staging of mediastinal lymph nodes
    • Considered completely resectable



  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Not specified


  • No severe liver disease


  • Creatinine no greater than 1.7 mg/dL


  • Adequate cardiac function
  • No cardiac disease that would preclude forced hydration or surgery


  • Predicted postoperative FEV_1 greater than 1 by spirometry


  • No contraindication to surgery
  • No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No uncontrolled infection
  • No uncontrolled diabetes
  • No neurologic or psychiatric disorders that would preclude study compliance
  • No other serious illnesses that would preclude study participation
  • No other circumstances that would preclude study participation


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior pleurectomy or lung resection except for diagnostic purposes

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): NCT00030745

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Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Rolf A. Stahel, MD UniversitaetsSpital Zuerich
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00030745    
Other Study ID Numbers: SAKK 17/00
SWS-SAKK-17-00 ( Other Identifier: SAKK )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
stage IA malignant mesothelioma
stage IB malignant mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs