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

September 13, 2010 updated by: Third Military Medical University

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)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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.
Radiation: 3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Drug: Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 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.
every 2 cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: every 3 month after Progressive Disease
after Progressive Disease, patient will be contact every 3 month for the survival information.
every 3 month after Progressive Disease
Time to Progressive Disease (RECIST Criteria)
Time Frame: 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.
Every 2 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 13, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DO201001
  • DO210101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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