Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC) (DO201001)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Third Military Medical University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Third Military Medical University

ClinicalTrials.gov Identifier:

NCT01201044

First received: May 24, 2010

Last updated: September 13, 2010

Last verified: December 2009

History of Changes

Purpose

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

Condition	Intervention
Non-small Cell Lung Cancer	Drug: Gemcitabine, Nedaplatin, iV Radiation: 3DCRT Drug: Gemcitabine，Nedaplatin, BAI

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Third Military Medical University:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
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 [ Time Frame: every 3 month after Progressive Disease ] [ Designated as safety issue: No ]
after Progressive Disease, patient will be contact every 3 month for the survival information.
Time to Progressive Disease (RECIST Criteria) [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	80
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gemcitabine, Nedaplatin,BAI plus 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..	Radiation: 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
Gemcitabine, Nedaplatin, IV Plus 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.	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.

Arms

Assigned Interventions

Experimental: Gemcitabine, Nedaplatin,BAI plus 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..

Radiation: 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

Gemcitabine, Nedaplatin, IV Plus 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201044

Contacts

Contact: YI LI

+86-113452081471

tumordoctor@163.com

Locations

China
The 3rd Affiliated Hospital of the 3rd Military Hospital	Recruiting
Chongqing, China
Contact: Yi Li +86-13452081471
Sub-Investigator: YI LI

Sponsors and Collaborators

Third Military Medical University

More Information

No publications provided

Responsible Party:	Yi Li, The Third Affiliated of the The Third Military Medical University Cancer Center
ClinicalTrials.gov Identifier:	NCT01201044 History of Changes
Other Study ID Numbers:	DO201001, DO210101
Study First Received:	May 24, 2010
Last Updated:	September 13, 2010
Health Authority:	China: Food and Drug Administration

Keywords provided by Third Military Medical University:

BAI
3DCRT

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Nedaplatin
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013

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