Non-small Cell Lung Cancer
Conditions
Keywords
BAI, 3DCRT
Brief summary
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.
Interventions
DRUGGemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
RADIATION3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
DRUGGemcitabine，Nedaplatin, BAI
Drug: Gemcitabine, Nedaplatin, iV Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | every 2 cycles | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | every 3 month after Progressive Disease | after Progressive Disease, patient will be contact every 3 month for the survival information. |
| Time to Progressive Disease (RECIST Criteria) | Every 2 cycles | Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans.Time to Progression (TTP) is defined as the time between randomisation and the date of the first documented disease progression. |
Countries
China
Contacts
Primary ContactYI LI
Outcome results
None listed