NCT00540280

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

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_3

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

Same day

First QC Date

October 4, 2007

Last Update Submit

March 6, 2011

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

  • OS, MS, DFS

    overall

Study Arms (1)

Surgery alone

ACTIVE COMPARATOR

Surgery alone

Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin

Interventions

Surgery alone or surgery plus preoperative Gemcitabine-CisplatinRADIATION

Surgery + Chemo + RT

Surgery alone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with early stage NSCLC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Khalid Rehman, MD

    King Faisal Specialist Hospital & Research Centre, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 5, 2007

Study Start

October 1, 2003

Primary Completion

October 1, 2003

Study Completion

October 1, 2013

Last Updated

March 8, 2011

Record last verified: 2011-03