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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02639767
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of malignant pleural mesothelioma at MSKCC
* No plans for surgical resection
* Stage T1-4, N0-3, M0
* No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
* Prior chemotherapy regimens ≤1
* Age ≥18 years
* Karnofsky performance status ≥ 80%
* Pulmonary function tests as follows: DLCO\>50% predicted
* Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Calculated creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft \& Gault method)
* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
* AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
Exclusion Criteria:
* Pregnant or lactating women, or men or women not using effective contraception
* Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
* Patients with a concurrent active malignancy (with the exception of skin cancer)
* Patients with serious unstable medical illness
* Patients with idiopathic pulmonary fibrosis
* Patients with NYHA heart failure class \>2
* Patients with only one kidney that is ipsilateral to the mesothelioma
* Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
* Patients meeting the following exclusion criteria will be excluded from the MRI portion only:
* Metallic implant, e.g. pacemaker, defibrillator
* Unmanageable claustrophobia
* High risk for nephrogenic systemic fibrosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02639767
Study Brief:
Protocol Section:
NCT02639767