Palliative pleurectomy / decortication in patients with malignant pleural mesothelioma after standard chemotherapy. A multicenter, randomised, phase III study. - Palliative pleurectomy in pleural mesothelioma after standard chemotherapy

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites160 target enrollmentTBD

Conditionsmesothelioom 10027412 10035597 10006295

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: mesothelioom
Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment: 160
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

Erasmus MC, Universitair Medisch Centrum Rotterdam

Eligibility Criteria

Inclusion Criteria

•Fit enough to undergo pleurectomy / decortication after 4\-6 courses cisplatinum\- pemetrexed.;Histological proven malignant pleural mesothelioma;Any T, except extension to contralateral pleura, abdomen, or invasion of the myocardium, any N any M.;Performance status WHO 0 or 1;Weight loss \< 10% in last 3 months;Standard chemotherapy with pemetrexed and cisplatin which must have resulted in CR, PR or SD;No prior chest radiotherapy ;No prior or other malignancies, except if longer than 5 yrs ago and adequately treated;No uncontrolled infection

Exclusion Criteria

•Objective progressive disease after 4\-6 cycles of standard chemotherapy with cisplatin and pemetrexed.;Ongoing grade \>\=2 toxicity (CTC v 3\.0\) due to prior standard chemotherapy other than alopecia, polyneuropathy and tinnitus.;Weight loss \> 10% in last 3 months before randomisation;Prior chest radiotherapy (except radiotherapy on chest tube port).;Prior or current other malignancies, except if longer than 5 years ago and adequately treated.;No other severe medical illness, including psychosis. ;Any concurrent anti\-cancer treatment or use of investigational drugs. Palliative radiotherapy is allowed.;Uncontrolled infections

Outcomes

Primary Outcomes

Not specified

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