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

NCT01363557 | Terminated

• 2 other identifiers: P1006012010-A01332-37
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

EGFR-mutated Lung Adenocarcinoma; Brain Metastasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  at 6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Arm A : Gefitinib + WBRT

EXPERIMENTAL

Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance

Other: whole brain radiotherapy

Arm B : Gefitinib

EXPERIMENTAL

Arm B : Gefitinib alone

Drug: Gefitinib (IRESSA)

Interventions

whole brain radiotherapy OTHER

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

Arm A : Gefitinib + WBRT

Gefitinib (IRESSA) DRUG

250 mg/day

Arm B : Gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have signed a written informed consent form prior to any study specific screening procedures
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Service de Neurologie - Hôpital Avicenne

Bobigny, 93009, France

Location

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Antoine CARPENTIER, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: June 1, 2011
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

FR (1)