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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


N/A
18 Years
N/A
Open (Enrolling)
Both
EGFR-mutated Lung Adenocarcinoma, Brain Metastasis

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

at 6 weeks

Safety Issue:

Yes

Principal Investigator

Antoine CARPENTIER, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P100601

NCT ID:

NCT01363557

Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • EGFR-mutated Lung Adenocarcinoma
  • Brain Metastasis
  • Randomized
  • Brain Radiation Therapy
  • Lung Cancer
  • Brain Metastasis
  • Gefitinib
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

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