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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01363557
Eligibility Criteria:
Inclusion Criteria:
* Patients must have signed a written informed consent form prior to any study specific screening procedures
* 18 years or older
* KPS ≥ 50%
* Histologically confirmed adenocarcinoma of the lung
* Activating mutation of EGFR
* Newly diagnosed CNS metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion \> 1 cm on T1-weighted contrast enhanced MRI)
* Patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except TKI.
* No steroids or stable or decreasing dose of steroids for at least 5 days before the MRI evaluation.
* Adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; Hb ≥ 9 g/Dl; Total bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN (\< 5 x ULN in patients with liver metastases); Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min
Exclusion Criteria:
* Prior treatment of brain metastases with WBRT or TKI
* Patient eligible for radiosurgery or surgical resection
* Contre indication at the radiotherapy
* Leptomeningeal disease
* Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry
* Prior treatment with Gefitinib or other TKI
* Pregnant or breast feeding women
* Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01363557
Study Brief:
Protocol Section:
NCT01363557