We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer

This study has suspended participant recruitment.
(Follow up only)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540280
First Posted: October 5, 2007
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
King Faisal Specialist Hospital & Research Center
  Purpose
Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • OS, MS, DFS [ Time Frame: overall ]

Estimated Enrollment: 10
Study Start Date: October 2003
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery alone
Surgery alone
Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin
Surgery + Chemo + RT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with early stage NSCLC
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540280


Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Khalid Rehman, MD King Faisal Specialist Hospital & Research Centre, Saudi Arabia
  More Information

Responsible Party: Naeem Chaudhri, MD, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00540280     History of Changes
Other Study ID Numbers: RAC#2031-059
First Submitted: October 4, 2007
First Posted: October 5, 2007
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by King Faisal Specialist Hospital & Research Center:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs