Carcinoma, Non-Small-Cell LungPhase 3NCT00540280
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer
A Phase 3 study testing Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by King Faisal Specialist Hospital & Research Center.
Trial summary
Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with early stage NSCLC
Who cannot join
None listed.
About this study
Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery alone or surgery plus preoperative Gemcitabine-CisplatinRadiation
Surgery + Chemo + RT
| Study group | Role | What they receive |
|---|---|---|
| Surgery alone | Active comparator | Surgery alone Receives: Radiation: Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS, MS, DFS
Measured: overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startOct 2003
- Primary completionOct 2003 (estimated)
- Study completionOct 2013 (estimated)
Why it stopped: Follow up only
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Khalid Rehman, MD, Principal investigator, King Faisal Specialist Hospital & Research Centre, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540280
- Sponsor's protocol ID
- RAC#2031-059
- Status last verified
- Mar 2011
- First submitted
- 4 Oct 2007
- Last updated
- 8 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00540280
- Acronym / sponsor ID
- RAC#2031-059
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Follow up only
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2003 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery alone | Active comparator | Radiation: Surgery alone or surgery plus preoperative Gemcitabine-CisplatinSurgery alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with early stage NSCLC
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery alone or surgery plus preoperative Gemcitabine-CisplatinSurgery + Chemo + RT | Radiation | Surgery alone |
Primary outcome
OS, MS, DFS
Time frame: overall
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid Rehman, MD principal investigator
King Faisal Specialist Hospital & Research Centre, Saudi Arabia
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by King Faisal Specialist Hospital & Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS, MS, DFS (time frame: overall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011; AzTrials last refreshed its copy on 31 Oct 2026.