Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Radiation: Prophylactic cranial irradiation
- Registration Number
- NCT01158170
- Lead Sponsor
- Zhejiang Cancer Hospital
- Brief Summary
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
- Detailed Description
OBJECTIVES:
Primary
Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.
Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Patients were required to have histologically or cytologically documented
- NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
- No previous history of radiotherapy and surgery of brain
- good response( CR/PR) to Erlotinib or Gefitinib.
- Agree to radiotherapy
- age > 18 and <75 years,ECOG performance status 1 or less
- Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
- Have provided informed consent
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description prophylactic cranial irradiation Prophylactic cranial irradiation Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions. prophylactic cranial irradiation Erlotinib /Gefitinib Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions. Conctrol Erlotinib /Gefitinib Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
- Primary Outcome Measures
Name Time Method The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) 2.5years
- Secondary Outcome Measures
Name Time Method overall survival baseline to date of death from any cause
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China