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:
Information provided by:
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00540280
First received: October 4, 2007
Last updated: March 6, 2011
Last verified: March 2011
  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: 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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with early stage NSCLC
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 4, 2007
Last Updated: March 6, 2011
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014