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NCT Number: NCT00191763

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell-Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

Cisplatin

Drug

Primary outcomes

  1. To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer

Secondary outcomes

  1. To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin

  2. To determine the complete tumor resection rate

  3. To evaluate overall survival and time to documented disease progression

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer

Important dates

Study start
2002
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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