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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01363557

Acronym

ARPEGE

Enrollment

Registered

2011-06-01

Start date

2012-03-31

Completion date

2013-05-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR-mutated Lung Adenocarcinoma, Brain Metastasis

Keywords

Randomized, Brain Radiation Therapy, Lung Cancer, Brain Metastasis, Gefitinib

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

Interventions

OTHERwhole 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

DRUGGefitinib (IRESSA)

250 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026