A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
18 Years
70 Years
Both
Non-small Cell Lung Cancer
Trial Information
A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- stage IIIA&IIIB NSCLC
- male or female, Age ≥18Years, ≤70Years
- Life expectation of at least 12weeks.
- PS performance 0-2
- Measurable disease according to the Response Evaluation Criteria in Solid Tumours (
RECIST)
Exclusion Criteria:
- Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans, and overall survival.The primary efficacy variable is progression free survival (PFS), defined as the time between randomisation and the date of first documented disease progression or death from any cause, whichever comes first. Disease progression is defined according to the RECIST criteria.
Outcome Time Frame:
every 2 cycles
Safety Issue:
No
Authority:
China: Food and Drug Administration
Study ID:
DO201001
NCT ID:
NCT01201044
Start Date:
January 2010
Completion Date:
December 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- BAI
- 3DCRT
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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