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

Assistance Publique - Hôpitaux de Paris1 site in 1 country1 target enrollmentMarch 2012

ConditionsEGFR-mutated Lung Adenocarcinoma Brain Metastasis

Interventionswhole brain radiotherapy Gefitinib (IRESSA)

Overview

Phase: Not Applicable
Intervention: whole brain radiotherapy
Conditions: EGFR-mutated Lung Adenocarcinoma
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 1
Locations: 1
Primary Endpoint: To assess the objective response rate of brain metastases in each arm
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

May 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

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

Arms & Interventions

Arm A : Gefitinib + WBRT

Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance

Intervention: whole brain radiotherapy

Arm B : Gefitinib

Arm B : Gefitinib alone

Intervention: Gefitinib (IRESSA)

Outcomes

Primary Outcomes

To assess the objective response rate of brain metastases in each arm

Time Frame: at 6 weeks

Secondary Outcomes

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)