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NCT Number: NCT00191126

Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician., Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Main inclusion Criteria:

  • Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
  • ECOG Performance Status of 0 - 1
  • Bidimensionally measurable disease or evaluable disease
  • Adequate organ function

Main exclusion Criteria:

  • Have greater than Grade 1 neuropathy - motor/sensory
  • Significant history of cardiac disease
  • Pleural effusion

Treatment and study plan

Gemcitabine

Drug

1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles

Other names: LY188011, Gemzar

Cisplatin

Drug

75 mg/m2, IV, q 21 days x 3 cycles

Surgery

Procedure

surgery

Primary outcomes

  1. Progression free survival

    Time frame: baseline to measure progressive disease

Secondary outcomes

  1. To compare the survival and sites of relapse in the two study arms.

    Time frame: baseline to progressive disease

  2. Pharmacology toxicity

    Time frame: every cycle

  3. Response rate

    Time frame: baseline to measured progressive disease

  4. Pathologic response rate of tissue samples

    Time frame: baseline, post chemotherapy, post surgery

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Sep 12, 2019

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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