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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT00165503
Eligibility Criteria:
Inclusion Criteria:
* Histopathologic confirmation of malignant pleural mesothelioma
* Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion or those with minimal disease
* Male on non-pregnant female
* 18 years of age or older
* No evidence of spread outside the ipsilateral hemithorax by chest CT and chest MRI
* Ejection fraction \> 45%
* Pre-operative WBC \> 4K/uL
* Estimated life expectancy of at least 12 weeks
* Evidence of adequate renal and hepatic function
* Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan
* Karnofsky performance status of 70% or greater
* No evidence of disease progression by chest CT or chest MRI, obtained at 8 weeks following surgery
Exclusion Criteria:
* Extended disease outside the ipsilateral hemithorax as determined on pre-operative radiographs or intraoperative findings
* Positive extrapleural nodes as determined by mediastinoscopy
* Gross disease (estimated thickness \> 10mm at any intrathoracic location) present within the hemithorax after surgery
* Evidence of distant metastatic disease
* Severe non-malignant co-morbid disease, uncontrolled angina, myocardial infarction on the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
* Pregnant or breast-feeding
* Serious concomitant systemic disorders
* Presence of active concomitant malignancy
* Psychiatric or addictive disorders, which would preclude informed consent
* Previous chemotherapy or radiation therapy for mesothelioma
* Chemotherapy or radiation therapy administered within 3 years for another malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00165503
Study Brief:
Protocol Section:
NCT00165503