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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Aug 2002

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

August 1, 2002

Completed

4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

6.8 years

First QC Date

July 19, 2006

Last Update Submit

July 10, 2025

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesotheliomasarcomatous mesotheliomaadvanced malignant mesotheliomaepithelial mesothelioma

Outcome Measures

Primary Outcomes (1)

Best Response
Best response to chemotherapy after induction
After 2-4 cycles of induction chemotherapy (28 day cycle)

Secondary Outcomes (3)

Tolerability and toxicity
After 2-4 cycles of induction chemotherapy (28 day cycle)
Relapse free and overall survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Assess Patient Quality of Life
Prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (Average 10 years)

Study Arms (1)

Induction Combination Chemotherapy

EXPERIMENTAL

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

Drug: CisplatinDrug: MethotrexateDrug: Vinorelbine ditartrateProcedure: Adjuvant therapyProcedure: Conventional surgeryProcedure: Neoadjuvant TherapyRadiation: 3-dimensional conformal radiation therapyRadiation: Intensity-modulated radiation therapy