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

Not Applicable

Terminated

• Conditions: EGFR-mutated Lung Adenocarcinoma; Brain Metastasis
• Interventions: Other: whole brain radiotherapy; Drug: Gefitinib (IRESSA)

• Registration Number: NCT01363557
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-01
• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2013-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A : Gefitinib + WBRT	whole brain radiotherapy	Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance
Arm B : Gefitinib	Gefitinib (IRESSA)	Arm B : Gefitinib alone

Primary Outcome Measures

Name	Time	Method
To assess the objective response rate of brain metastases in each arm	at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants with neurological Adverse Events	at 6 weeks, 3 months, 4.5 months and 6 months
Progression-free survival (PFS)	at 6 months
Overall survival	at 6 months

Trial Locations

Locations (1)

Service de Neurologie - Hôpital Avicenne; 🇫🇷 Bobigny, France