Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01201044
• Other study ID #: DO201001
• Secondary ID: DO210101
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2010
• Last updated: September 13, 2010
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2009
• Source: Third Military Medical University
• Contact: YI LI
• Phone: +86-113452081471
• Email: tumordoctor[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.

Radiation:
• 3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
• 3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.

Drug:
• Gemcitabine,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

Locations

Country	Name	City	State
China	The 3rd Affiliated Hospital of the 3rd Military Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Survival	after Progressive Disease, patient will be contact every 3 month for the survival information.	every 3 month after Progressive Disease	No
Secondary	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.	Every 2 cycles	No