Back to resultsStudy to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC) (DO201001)
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gemcitabine, Nedaplatin, iV
3DCRT
3DCRT
Gemcitabine，Nedaplatin, BAI
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring BAI, 3DCRT
Eligibility Criteria
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
Sites / Locations
- The 3rd Affiliated Hospital of the 3rd Military HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gemcitabine, Nedaplatin,BAI plus 3DCRT
Gemcitabine, Nedaplatin, IV Plus 3DCRT
Arm Description
Gemcitabine(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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival
after Progressive Disease, patient will be contact every 3 month for the survival information.
Time to Progressive Disease (RECIST Criteria)
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.
Full Information
NCT ID
NCT01201044
First Posted
May 24, 2010
Last Updated
September 13, 2010
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01201044
Brief Title
Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
Acronym
DO201001
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Third Military Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
BAI, 3DCRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine, Nedaplatin,BAI plus 3DCRT
Arm Type
Experimental
Arm Description
Gemcitabine(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..
Arm Title
Gemcitabine, Nedaplatin, IV Plus 3DCRT
Arm Type
Other
Arm Description
Gemcitabine 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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Nedaplatin, iV
Intervention Description
Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
Intervention Type
Radiation
Intervention Name(s)
3DCRT
Intervention Description
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Intervention Type
Radiation
Intervention Name(s)
3DCRT
Intervention Description
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine，Nedaplatin, BAI
Intervention Description
Drug: Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI
Primary Outcome Measure Information:
Title
Progression Free Survival
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.
Time Frame
every 2 cycles
Secondary Outcome Measure Information:
Title
Overall Survival
Description
after Progressive Disease, patient will be contact every 3 month for the survival information.
Time Frame
every 3 month after Progressive Disease
Title
Time to Progressive Disease (RECIST Criteria)
Description
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.
Time Frame
Every 2 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YI LI
Phone
+86-113452081471
Email
tumordoctor@163.com
Facility Information:
Facility Name
The 3rd Affiliated Hospital of the 3rd Military Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li
Phone
+86-13452081471
First Name & Middle Initial & Last Name & Degree
YI LI
12. IPD Sharing Statement
Learn more about this trial
Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
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