Clinical trial NCT01363557: Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: EGFR-mutated Lung Adenocarcinoma
Brain Metastasis
Keywords: Randomized
Brain Radiation Therapy
Lung Cancer
Brain Metastasis
Gefitinib
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-06-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: To assess the objective response rate of brain metastases in each arm
timeFrame: at 6 weeks
Secondary outcomes:
measure: Number of Participants with neurological Adverse Events
timeFrame: at 6 weeks, 3 months, 4.5 months and 6 months
measure: Progression-free survival (PFS)
timeFrame: at 6 months
measure: Overall survival
timeFrame: at 6 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Service de Neurologie - Hôpital Avicenne
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antoine CARPENTIER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: