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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT00165516
Eligibility Criteria:
Inclusion Criteria:
* Male of non-pregnant female 18 years of age or older
* HIstopathologic confirmation of malignant pleural mesothelioma
* Ejection fraction \> 45%
* Evidence of adequate renal and hepatic function
* Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates
* FEV1 \> or = to 2.0L on a preoperative pulmonary function test
* Karnofsky performance status of 70% or greater
Exclusion Criteria:
* Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings
* Positive extrapleural nodes as determined by mediastinoscopy
* Positive LENIs
* Gross disease present within the hemithorax after surgery
* Evidence of distant metastases
* Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
* Presence of active concomitant malignancy
* Patients with a psychiatric or addictive disorder which would preclude informed consent
* Previous chemotherapy or radiation therapy to treat mesothelioma
* Chemotherapy or radiation therapy administered within 3 years for another malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00165516
Study Brief:
Protocol Section:
NCT00165516