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

NCT00191126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2019-09-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

gemcitabine

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

DRUG

Cisplatin

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

PROCEDURE

surgery

surgery

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Egypt
  • Estonia
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Romania
  • Saudi Arabia
  • Slovakia
  • Sweden
  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191126 on ClinicalTrials.gov