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

NCT ID: NCT01201044

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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..

Group Type EXPERIMENTAL

3DCRT

Intervention Type RADIATION

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

Gemcitabine,Nedaplatin, BAI

Intervention Type DRUG

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.

Group Type OTHER

Gemcitabine, Nedaplatin, iV

Intervention Type DRUG

Gemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.

3DCRT

Intervention Type RADIATION

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

Interventions

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Gemcitabine, Nedaplatin, iV

Gemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.

Intervention Type DRUG

3DCRT

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

Intervention Type RADIATION

3DCRT

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

Intervention Type RADIATION

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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The Third Affiliated of the The Third Military Medical University Cancer Center

Locations

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The 3rd Affiliated Hospital of the 3rd Military Hospital

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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YI LI

Role: CONTACT

+86-113452081471

Facility Contacts

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Yi Li

Role: primary

+86-13452081471

Other Identifiers

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DO210101

Identifier Type: -

Identifier Source: secondary_id

DO201001

Identifier Type: -

Identifier Source: org_study_id