Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Treatments: Gefitinib

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