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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT00354393
Phase
PHASE2
Status
Completed

Conditions

  • Malignant Mesothelioma

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
  • Methotrexate — DRUG
  • Vinorelbine ditartrate — DRUG
  • Adjuvant therapy — PROCEDURE
  • Conventional surgery — PROCEDURE
  • Neoadjuvant Therapy — PROCEDURE
  • 3-dimensional conformal radiation therapy — RADIATION
  • Intensity-modulated radiation therapy — RADIATION

Study Details

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.

Key Dates

Start date
Aug 31, 2002
Status verified
Jul 2025
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Combination Chemotherapy
    Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses. Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology \& T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery. Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication \& are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy \& proceed to chemoradiotherapy. Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 \& 22. Patients w/ responding disease proceed to adjuvant chemotherapy. Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy

Primary Outcome Measure

Best Response [ Time Frame: After 2-4 cycles of induction chemotherapy (28 day cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer CenterClevelandOhio44106-5065-

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By research site
Case Comprehensive Cancer Center· Cleveland, OH

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