- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158170
Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Shenglin Ma, MD
- Phone Number: +8657188122568
- Email: mashenglin@medmail.com.cn
Study Contact Backup
- Name: Yaping Xu, MD
- Phone Number: +8657188122082
- Email: xuyaping1207@gmail.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- ZheJiang Cancer Hospital
-
Contact:
- XuYa ping, MD
- Phone Number: 0086-571-88122082
- Email: xuyaping1207@gmail.com
-
Hangzhou, Zhejiang, China
- Recruiting
- ZheJiang Cancer Hospital
-
Contact:
- Shenglin Ma, MD
- Phone Number: +8657188122568
- Email: mashenglin@medmail.com.cn
-
Contact:
- Yaping Xu, MD
- Phone Number: +8657188122082
- Email: xuyaping1207@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: prophylactic cranial irradiation
Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
|
25GY/10fraction
Other Names:
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Other Names:
|
Active Comparator: Conctrol
Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
|
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
Time Frame: 2.5years
|
2.5years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: baseline to date of death from any cause
|
baseline to date of death from any cause
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shenglin Ma, MD, ZheJiang Cancer Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Gefitinib
Other Study ID Numbers
- ZhejiangCH06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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