Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer
Sponsor
King Faisal Specialist Hospital & Research Center (Other)
Overall Status
Suspended
CT.gov ID
NCT00540280
Collaborator
(none)
10
1
120
Study Details
Study Description
Brief Summary
Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Oct 1, 2003
Anticipated Primary Completion Date
:
Oct 1, 2003
Anticipated Study Completion Date
:
Oct 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Surgery alone Surgery alone |
Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin
Surgery + Chemo + RT
|
Outcome Measures
Primary Outcome Measures
- OS, MS, DFS [overall]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with early stage NSCLC
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- King Faisal Specialist Hospital & Research Center
Investigators
- Principal Investigator: Khalid Rehman, MD, King Faisal Specialist Hospital & Research Centre, Saudi Arabia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00540280
Other Study ID Numbers:
- RAC#2031-059
First Posted:
Oct 5, 2007
Last Update Posted:
Mar 8, 2011
Last Verified:
Mar 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms: