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

Not Applicable

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: 3DCRT; Drug: Gemcitabine, Nedaplatin, iV; Drug: Gemcitabine，Nedaplatin, BAI

• Registration Number: NCT01201044
• Lead Sponsor: Third Military Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-01
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-09-13
• Last Update Submitted: 2010-09-13
• Study First Posted: 2010-09-14
• Last Update Posted: 2010-09-14
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine, Nedaplatin,BAI plus 3DCRT	3DCRT	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, Nedaplatin,BAI plus 3DCRT	Gemcitabine，Nedaplatin, BAI	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, Nedaplatin, IV Plus 3DCRT	Gemcitabine, Nedaplatin, iV	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.
Gemcitabine, Nedaplatin, IV Plus 3DCRT	3DCRT	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The 3rd Affiliated Hospital of the 3rd Military Hospital; 🇨🇳 Chongqing, China