Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT02662504
Eligibility Criteria:
Inclusion Criteria:
* histologically-proved epithelioid malignant pleural mesothelioma (MPM) on biopsies obtained before eP/D surgery
* tumor stage: no tumor extension to controlateral lung, mediastinum, peritoneum or myocardium (\<T4); mediastinal lymph nodes extension: cN2 but no bulky N2 or N3), no metastasis (M0)
* Performance status WHO PS 0-1
* patients fit to have surgery (eP/D) and chemotherapy (cisplatin-pemetrexed), based on clinical examination, complete normal biological work-up, full assessment by cardiac and pulmonary function tests. Predicted post-surgical values should be sufficient for normal daily life: FEV1\>40%; pre-surgical DLCO\>50% predicted value and VO2max \>15 ml/min/kg; (left ventricular) cardiac function \>50% and no significant pulmonary artery hypertension
* written informed consent must be obtained before inclusion and randomization
Exclusion Criteria:
* Another histologic subtype than epithelioid MPM at the time of diagnosis
* Bulky N2, N3 and/or M1 stage (UICC/IMIG 1995)
* prior chemotherapy for mesothelioma
* prior radiotherapy of thorax, neck or upper abdomen
* other malignancy treated within 5 years, except basal cell carcinoma or in situ carcinoma of the cervix
* contra-indication for MPM surgery or chemotherapy (cisplatin and pemetrexed): cardiac failure, pulmonary hypertension, liver or kidney dysfunction (GFR\<60 ml/min), uncontrolled infection, previous major neurotoxicity or ototoxicity,... or other severe condition according to the investigator
* pregnancy or breast feeding
* contra-indication for porfimer sodium (Photofrin): porphyria or known hypersensitivity to porphyrins, severe hepatic impairment, tracheo-oesophageal or broncho-oesophageal fistula, suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage
* A previous talc pleurodesis during diagnostic thoracoscopy is NOT an exclusion criteria but talc on mediastinal pleura should be avoided to not keep away from eP/D.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02662504
Study Brief:
Protocol Section:
NCT02662504