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)
1 other identifier
interventional
200
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
Started Jun 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 8, 2010
July 1, 2010
2.9 years
June 23, 2010
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
2.5years
Secondary Outcomes (1)
overall survival
baseline to date of death from any cause
Study Arms (2)
prophylactic cranial irradiation
EXPERIMENTALPatients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
Conctrol
ACTIVE COMPARATORPatients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
Interventions
25GY/10fraction
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shenglin Ma, MD
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 23, 2010
First Posted
July 8, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2013
Study Completion
December 1, 2013
Last Updated
July 8, 2010
Record last verified: 2010-07