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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02966769
Enrollment
294
Registered
2016-11-17
Start date
2016-06-30
Completion date
2017-03-31
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemoradiation, Non-small-Cell Lung Carcinoma, Stage IIIA-N2, Surgery, Survival

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.

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.

Interventions

OTHEROverall survival

Compare overall survival between both groups.

Sponsors

Grupo de Investigación Clínica en Oncología Radioterapia
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* T4 or N3 stage. * Bulky disease or not resectable.

Design outcomes

Primary

MeasureTime frame
Overall survival5 years

Secondary

MeasureTime frame
Disease-free survival5 years
Patterns of Relapse5 years
Mortality5 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026