eoadjuvant chemotherapy and extrapleural pneumonectomy of malignant pleural mesothelioma (MPM) with or without hemithoracic radiotherapy. A randomized multicenter phase II trial

Conditions: Patients with pleural mesothelioma, T<=3, N<=2, M0 (IMIG-system)
MedDRA version: 9.1Level: LLTClassification code 10035603Term: Pleural mesothelioma

Registration Number: EUCTR2006-000445-19-DE

Lead Sponsor: Swiss group for clinical cancer research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 155

Inclusion Criteria

Inclusion Criteria for Part 1:
- Histological/cytological proof of malignant pleural mesothelioma
- T<=3, N<=2, M0 according to the IMIG staging system
- Patients must have a WHO performance score of 0-1 and to be considered fit for chemotherapy, surgery and postoperative radiotherapy
- Age 18-70
- Normal hematologic function (hemoglobin >=100g/l, WBC >= 3.5 x 10^9/l, neutrophils >= 1.5 x 10^9/l, thrombocytes >=100 x 10^9/l)
- Bilirubin and liver function tests (ASAT/ALAT/AP) <= 1.5 LUN
- Written informed consent for PArt 1 has been obtained
Inclusion Criteria for Part 2:
- Macroscopically complete resection (R0 or R1)
- Written informed consent for Part 2 has been obtained
-- Normal hematologic function (hemoglobin >110g/l, WBC > 3.5 x 10^9/l, neutrophils >= 1.5 x 10^9/l, thrombocytes >=100 x 10^9/l)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria for Part 1:
- Obvious invasion of mediastinal structures on CT scan
- Obvious widespread chest wall invasion
- Prior chemotherapy
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment within a clinical trial within 30 days prior to trial entry
- Prior pleurectomy and lung resection, prior radiotherapy of the lower neck, thorax and upper abdomen
- Any concomitant drugs contraindicated for use with the trial drugs
- Any known hypersensitivity against pemetrexed or cisplatin or other platin containing substances or any other components used for the preparation of the drugs
- Concomitant vaccination against yellow fever
- Restricted power of hearing (especially in the upper frequency range)
- Patients suffering from exsiccosis
- Patients with acute infections
Exclusion criteria for Part 2:
- Macroscopically incomplete resection (R2)