Non-small-Cell Lung CarcinomaNCT02966769
N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation
An observational study of Non-small-Cell Lung Carcinoma and Surgery, run by Grupo de Investigación Clínica en Oncología Radioterapia at 1 site in Spain.
Trial summary
The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small-Cell Lung Carcinoma, Surgery, Stage IIIA-N2
- What is being tested?
- Overall survival
- How many people
- 294 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Mar 2017
- Phase
- Observational
- 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
Study population: Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.
Who may be able to join
- Stage IIIA (N2) disease
- Potentially resectable disease
- Stage Lung Cancer with CT scan or PET-CT.
- N2 involvement: it is not necessary pathological proof.
- No progression after induction treatment.
Who cannot join
- T4 or N3 stage.
- Bulky disease or not resectable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2
The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.
Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.
Read the detailed description
Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.
The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.
- Conditions
- Non-small-Cell Lung Carcinoma, Surgery, Stage IIIA-N2, Chemoradiation, Survival
- Being tested
- Overall survival
- 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.
Overall survivalOther
Compare overall survival between both groups.
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation Group | Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (>/= 60 Gy) plus Platinum-based Chemotherapy Receives: Other: Overall survival | |
| Neoadjuvant treatment plus Surgery Group | Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus >/= 45Gy) followed by Surgery Receives: Other: Overall survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (3)
Disease-free survival
Measured: 5 years
Patterns of Relapse
Measured: 5 years
Mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-Cell Lung CarcinomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Couñago, Grupo de Investigación Clínica en Oncología Radioterapia
- Investigators
- Felipe Couñago, MD PhD, Principal investigator, Grupo de Investigación Clínica en Oncología RadioterapiaSara Montemuiño, MDPhd, Principal investigator, Grupo de Investigación Clínica en Oncología Radioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966769
- Sponsor's protocol ID
- GICOR -SEOR 5-16
- Status last verified
- Feb 2018
- First submitted
- 11 Nov 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2
- ClinicalTrials.gov ID
- NCT02966769
- Acronym / sponsor ID
- GICOR -SEOR 5-16
- Conditions
- Non-small-Cell Lung Carcinoma, Surgery, Stage IIIA-N2, Chemoradiation, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Nov 2016 (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.
The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.
Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.
Detailed description
Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.
The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation Group | – | Other: Overall survivalAnalyze overall survival in the group of patients treatment by Concurrent Radiotherapy (>/= 60 Gy) plus Platinum-based Chemotherapy |
| Neoadjuvant treatment plus Surgery Group | – | Other: Overall survivalAnalyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus >/= 45Gy) followed by Surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.
Key inclusion criteria (5 listed)
- Stage IIIA (N2) disease
- Potentially resectable disease
- Stage Lung Cancer with CT scan or PET-CT.
- N2 involvement: it is not necessary pathological proof.
- No progression after induction treatment.
Key exclusion criteria (2 listed)
- T4 or N3 stage.
- Bulky disease or not resectable.
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 |
|---|---|---|
| Overall survivalCompare overall survival between both groups. | Other | Chemoradiation Group, Neoadjuvant treatment plus Surgery Group |
Primary outcome
Overall survival
Time frame: 5 years
3 secondary outcomes
Disease-free survival
Time frame: 5 years
Patterns of Relapse
Time frame: 5 years
Mortality
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Felipe Couñago, MD PhD principal investigator
Grupo de Investigación Clínica en Oncología Radioterapia
Sara Montemuiño, MDPhd principal investigator
Grupo de Investigación Clínica en Oncología Radioterapia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small-Cell Lung Carcinoma and Surgery, run by Grupo de Investigación Clínica en Oncología Radioterapia at 1 site in Spain.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: 5 years). 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 19 Feb 2018.