Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
DO201001
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)
2 other identifiers
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 14, 2010
December 1, 2009
2.7 years
May 24, 2010
September 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
every 2 cycles
Secondary Outcomes (2)
Overall Survival
every 3 month after Progressive Disease
Time to Progressive Disease (RECIST Criteria)
Every 2 cycles
Study Arms (2)
Gemcitabine, Nedaplatin,BAI plus 3DCRT
EXPERIMENTALGemcitabine(1000mg/m2)，Nedaplatin(60mg/m2),BAI, Day 1/4weeks. 4weeks per cycle. Tumor assessment will be perforemd after 2 cycles. if no PD, patient will be treated with 3DCRTfor 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year..
Gemcitabine, Nedaplatin, IV Plus 3DCRT
OTHERGemcitabine 100mg/m2, D1 \& D8 every 4 weeks Nedaplatin 75mg/m2, D1 every 4 weeks. every 4 weeks per cycle. Tumor assessment will be performed after 2 cycles. if no PD, patient will be treated with 3DCRT for 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year.
Interventions
Gemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Drug: Gemcitabine, Nedaplatin, iV Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The 3rd Affiliated Hospital of the 3rd Military Hospital
Chongqing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2010
First Posted
September 14, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
September 14, 2010
Record last verified: 2009-12