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Completed

NCT Number: NCT02966769

N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

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.

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Chemoradiation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IIIA-N2 Surgery Survival Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Quiron Madrid

Madrid, 28290, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Overall survival

Other

Compare overall survival between both groups.

Primary outcomes

  1. Overall survival

    Time frame: 5 years

Secondary outcomes

  1. Disease-free survival

    Time frame: 5 years

  2. Patterns of Relapse

    Time frame: 5 years

  3. Mortality

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Other

Registry information

Official study title

Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2016
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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