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

Brain Metastasis Clinical Trial

— ARPEGE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01363557
• Other study ID #: P100601
• Secondary ID: 2010-A01332-37
• Status: Terminated
• Phase: N/A
• First received: May 25, 2011
• Last updated: May 12, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Brain Metastasis
• Brain Neoplasms
• EGFR-mutated Lung Adenocarcinoma
• Neoplasm Metastasis

Intervention

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

Drug:
• Gefitinib (IRESSA)
250 mg/day

Locations

Country	Name	City	State
France	Service de Neurologie - Hôpital Avicenne	Bobigny

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the objective response rate of brain metastases in each arm		at 6 weeks	Yes
Secondary	Number of Participants with neurological Adverse Events		at 6 weeks, 3 months, 4.5 months and 6 months	Yes
Secondary	Progression-free survival (PFS)		at 6 months	Yes
Secondary	Overall survival		at 6 months	Yes