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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00054002
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed malignant mesothelioma, including the following cell types:
* Mixed mesothelial
* Sarcomatous
* Stage I or II disease using the Butchart system as determined by CT scan or MRI
* Disease confined to 1 hemithorax
* No tumor involvement of esophagus or heart as evidenced by CT scan
* Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest
* N2 disease allowed if no contralateral pleural involvement
* No adenocarcinoma or nonmesothelioma sarcoma of the chest wall
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.5 g/dL (transfusion allowed)
Hepatic
* Bilirubin less than 3.0 mg/dL
* Alkaline phosphatase less than 2 times upper limit of normal (ULN)
* SGOT less than 2 times ULN
Renal
* Creatinine less than 3.0 mg/dL
Cardiovascular
* No myocardial infarction within the past 6 months
Pulmonary
* Arterial partial pressure of carbon dioxide (pCO\_2) less than 50 torr at rest
* Predicted postoperative FEV\_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min
* Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation
Other
* Not pregnant
* No other concurrent malignancy except nonmelanoma skin cancer
* No contraindication to general anesthetic
* No history of porphyria
* No indicated sensitivity to porfimer sodium
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 30 days since prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the chest
* No prior radiotherapy for mesothelioma
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00054002
Study Brief:
Protocol Section:
NCT00054002