Trimodality Therapy for Malignant Pleural Mesothelioma

Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01343264

Enrollment

200

Registered

2011-04-28

Start date

2002-11-30

Completion date

Unknown

Last updated

2011-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Mesothelioma

Keywords

Radical Pleurectomy, Pleurectomy/decortication, Cisplatin, Pemetrexed, Radiation

Brief summary

The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection. Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied. The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed diagnosis of MPM (all subtypes) * Clinical T1-3, N0-2, M0 disease. * No prior treatment for MPM. * Adequate renal and liver function * Adequate cardio-pulmonary reserves

Exclusion criteria

* Patients with unresectable disease * Patients with an active infection that require systemic treatments * Patients with a concurrent active malignancy. * Patients with serious medical illness.

Design outcomes

Primary

Measure	Time frame
To determine the overall 5-year survival rate.	5-years

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 months	Morbidity
Number of Participants with treatment related deaths as a Measure of Safety and Tolerability	3 months	Mortality
Recurrence	5 years	Occurence of tumor recurrence

Countries

Germany

Outcome results