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

NCT ID: NCT01363557

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-05-31

Brief 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.

Detailed Description

Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring > 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib

Conditions

EGFR-mutated Lung Adenocarcinoma; Brain Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A : Gefitinib + WBRT

Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance

Group Type: EXPERIMENTAL

whole brain radiotherapy

Intervention Type: OTHER

External beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day

Arm B : Gefitinib

Arm B : Gefitinib alone

Group Type: EXPERIMENTAL

Gefitinib (IRESSA)

Intervention Type: DRUG

250 mg/day

Interventions

whole brain radiotherapy

External beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day

Intervention Type: OTHER

Gefitinib (IRESSA)

250 mg/day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine CARPENTIER, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Neurologie - Hôpital Avicenne

Bobigny, , France

Countries

France

Other Identifiers

2010-A01332-37

Identifier Type: OTHER

Identifier Source: secondary_id

P100601

Identifier Type: -

Identifier Source: org_study_id