Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy

NCT ID: NCT00191841

Last Updated: 2006-07-24

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-02-28

Brief Summary

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To evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with operable NSCLC

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gemcitabine

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologic or cytologic diagnosis of operable non-small cell lung cancer (IB-IIIA)
* no prior chemotherapy
* WHO criteria for disease status assessment

Exclusion Criteria

* Concurrent administration of any other tumor therapy
* pregnant or breast feeding
* serious concomitant disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Barnaul, , Russia

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Moscow, , Russia

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Saint Petersburg, , Russia

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Ufa, , Russia

Site Status

Countries

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Russia

References

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Davidov MI, Polotzky BE, Marenich AF, Orlov SV, Lazarev AF, Skryabina LS, Pavlushkov EV, Semenchenya VA, Brichkova OY, Karaseva VV. Gemcitabine combined with cisplatin as neoadjuvant chemotherapy in stage IB-IIIA non-small cell lung cancer. Anticancer Drugs. 2011 Jul;22(6):569-75. doi: 10.1097/CAD.0b013e328342d50a.

Reference Type DERIVED
PMID: 21487288 (View on PubMed)

Other Identifiers

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B9E-VI-S327

Identifier Type: -

Identifier Source: secondary_id

7410

Identifier Type: -

Identifier Source: org_study_id