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:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT00354393
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant pleural mesothelioma
* Amenable to aggressive surgical resection, if deemed resectable
* Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage
* Resectable disease is defined as any of the following:
* Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
* Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
* Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
* Disease considered unresectable by any medical reason or if surgery was declined
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* WBC ≥ 3,000/mm³
* Platelet count \> 100,000/mm³
* Creatinine ≤ 1.7 mg/dL
* Alkaline phosphatase \< 2 times normal
* AST \< 2 times normal
* Albumin \> 3 g/dL
* Bilirubin \< 2.0 mg/dL
* Patients must be available for and compliant with adequate long-term follow-up
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
* No other active malignancies
PRIOR CONCURRENT THERAPY:
* No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00354393
Study Brief:
Protocol Section:
NCT00354393