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

Swiss group for clinical cancer research0 个研究点目标入组 155 人开始时间: 2007年3月29日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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 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)

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