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

Primary Purpose

EGFR-mutated Lung Adenocarcinoma, Brain Metastasis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
whole brain radiotherapy
Gefitinib (IRESSA)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EGFR-mutated Lung Adenocarcinoma focused on measuring Randomized, Brain Radiation Therapy, Lung Cancer, Brain Metastasis, Gefitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Neurologie - Hôpital Avicenne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A : Gefitinib + WBRT

Arm B : Gefitinib

Arm Description

Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance

Arm B : Gefitinib alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with neurological Adverse Events
Progression-free survival (PFS)
Overall survival

Full Information

First Posted
May 25, 2011
Last Updated
May 12, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01363557
Brief Title
Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Decision of Sponsor
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGFR-mutated Lung Adenocarcinoma, Brain Metastasis
Keywords
Randomized, Brain Radiation Therapy, Lung Cancer, Brain Metastasis, Gefitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A : Gefitinib + WBRT
Arm Type
Experimental
Arm Description
Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance
Arm Title
Arm B : Gefitinib
Arm Type
Experimental
Arm Description
Arm B : Gefitinib alone
Intervention Type
Other
Intervention Name(s)
whole brain radiotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Gefitinib (IRESSA)
Intervention Description
250 mg/day
Primary Outcome Measure Information:
Title
To assess the objective response rate of brain metastases in each arm
Time Frame
at 6 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with neurological Adverse Events
Time Frame
at 6 weeks, 3 months, 4.5 months and 6 months
Title
Progression-free survival (PFS)
Time Frame
at 6 months
Title
Overall survival
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine CARPENTIER, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie - Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France

12. IPD Sharing Statement

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

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