Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-12-31

Brief Summary

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Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell-Lung Cancer

Study Design

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Allocation Method

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

* define histologic or cytologic diagnosis of non small cell lung cancer.
* determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.
* define performance status of 0-1 on ECOG scale
* do not have any prior tumor therapy
* to be suitable for curative resection

Exclusion Criteria

* to have any treatment within the last 30 days with any investigational drug.
* to get concurrent administration of any other tumor therapy
* to be pregnant
* to have poorly controlled diabetes mellitus
* to have serious concomitant disorders.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B9E-VI-S314

Identifier Type: -

Identifier Source: secondary_id

7138