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

Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis

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.

Study Overview

• Status: Terminated
• Conditions: Brain Metastasis; EGFR-mutated Lung Adenocarcinoma
• Intervention / Treatment: Other: whole brain radiotherapy; Drug: Gefitinib (IRESSA)

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93009
    • Service de Neurologie - Hôpital Avicenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A : Gefitinib + WBRT; Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance	Other: 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
EXPERIMENTAL: Arm B : Gefitinib; Arm B : Gefitinib alone	Drug: Gefitinib (IRESSA); 250 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the objective response rate of brain metastases in each arm	at 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Antoine CARPENTIER, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: May 31, 2011
• First Posted (ESTIMATE): June 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Lung Cancer; Randomized; Gefitinib; Brain Metastasis; Brain Radiation Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: P100601; 2010-A01332-37 (OTHER: IDRCB)