Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Prophylactic cranial irradiation
* Drug: Erlotinib /Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Seizure cannot be controled by the drugs Combined with other disease of the brain such as tumour or infarction Hypersensitivity to MR enhancer -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prophylactic cranial irradiation<br>Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions. | Radiation: Prophylactic cranial irradiation<br>* 25GY/10fraction<br>* Other names: PCI;Drug: Erlotinib /Gefitinib<br>* Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity<br>* Other names: EGFR-TKI;|
| Active Comparator: Conctrol<br>Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity | Drug: Erlotinib /Gefitinib<br>* Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity<br>* Other names: EGFR-TKI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) |  | 2.5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | baseline to date of death from any cause | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation