N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

February 15, 2018 updated by: Felipe Couñago, Grupo de Investigación Clínica en Oncología Radioterapia

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

294

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28290
        • Hospital Universitario Quiron Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chemoradiation Group
Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (>/= 60 Gy) plus Platinum-based Chemotherapy
Other: Overall survival
Compare overall survival between both groups.
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
Other: Overall survival
Compare overall survival between both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 5 years
5 years
Mortality
Time Frame: 5 years
5 years
Patterns of Relapse
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GICOR -SEOR 5-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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