N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation
Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2
1 other identifier
observational
294
1 country
1
Brief 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. Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 11, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 19, 2018
February 1, 2018
9 months
November 11, 2016
February 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
5 years
Secondary Outcomes (3)
Disease-free survival
5 years
Patterns of Relapse
5 years
Mortality
5 years
Study Arms (2)
Chemoradiation Group
Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (\>/= 60 Gy) plus Platinum-based Chemotherapy
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
Interventions
Compare overall survival between both groups.
Eligibility Criteria
Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.
You may qualify if:
- 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.
You may not qualify if:
- T4 or N3 stage.
- Bulky disease or not resectable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Quiron Madrid
Madrid, 28290, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Couñago, MD PhD
Grupo de Investigación Clínica en Oncología Radioterapia
- PRINCIPAL INVESTIGATOR
Sara Montemuiño, MDPhd
Grupo de Investigación Clínica en Oncología Radioterapia
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
November 11, 2016
First Posted
November 17, 2016
Study Start
June 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
February 19, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share