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Combination Chemotherapy With or Without Surgery and Chemoradiotherapy in Treating Patients With Malignant Pleural Mesothelioma

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: NCT00354393
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: cisplatin Drug: methotrexate Drug: vinorelbine ditartrate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Phase 2

Detailed Description:



  • Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.


  • Assess the tolerability and toxicity of this regimen in these patients.
  • Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.
  • Assess the impact of induction combination chemotherapy on operability and surgical success.
  • Evaluate the impact of these treatment regimens on quality of life.


  • Induction chemotherapy: Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8, 15, and 22. Treatment repeats every 28 days for 2 courses. Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy. Patients requiring palliative radiotherapy or who have progressive disease are removed from the study. Patients with resectable disease or sarcomatoid histology and T1-3, N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery.
  • Surgery: Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study. All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy.
  • Chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22. Patients with responding disease proceed to adjuvant chemotherapy.
  • Adjuvant chemotherapy: Patients receive 2 additional courses of MVP chemotherapy as above.

Quality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma
Study Start Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Primary Outcome Measures :
  1. Response to chemotherapy

Secondary Outcome Measures :
  1. Tolerability and toxicity
  2. Relapse free and overall survival
  3. Operability and surgical success
  4. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant pleural mesothelioma

    • Amenable to aggressive surgical resection, if deemed resectable

      • Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage

        • Resectable disease is defined as any of the following:

          • Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
          • Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
    • Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable

      • Disease considered unresectable by any medical reason or if surgery was declined


  • ECOG performance status 0-1
  • WBC ≥ 3,000/mm³
  • Platelet count > 100,000/mm³
  • Creatinine ≤ 1.7 mg/dL
  • Alkaline phosphatase < 2 times normal
  • AST < 2 times normal
  • Albumin > 3 g/dL
  • Bilirubin < 2.0 mg/dL
  • Patients must be available for and compliant with adequate long-term follow-up
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
  • No other active malignancies


  • No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer

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): NCT00354393

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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: David J. Adelstein, MD Case Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00354393     History of Changes
Other Study ID Numbers: CDR0000486304
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: October 2007
Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
sarcomatous mesothelioma
advanced malignant mesothelioma
epithelial mesothelioma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators