N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

NCT ID: NCT02966769

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chemoradiation Group

Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (\>/= 60 Gy) plus Platinum-based Chemotherapy

Overall survival

Intervention Type OTHER

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

Overall survival

Intervention Type OTHER

Compare overall survival between both groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Overall survival

Compare overall survival between both groups.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Grupo de Investigación Clínica en Oncología Radioterapia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Felipe Couñago

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Felipe Couñago, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Grupo de Investigación Clínica en Oncología Radioterapia

Sara Montemuiño, MDPhd

Role: PRINCIPAL_INVESTIGATOR

Grupo de Investigación Clínica en Oncología Radioterapia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Quiron Madrid

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GICOR -SEOR 5-16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy
NCT04564157 ACTIVE_NOT_RECRUITING PHASE3