N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

Completed

• Conditions: Stage IIIA-N2; Survival; Non-small-Cell Lung Carcinoma; Surgery; Chemoradiation
• Interventions: Other: Overall survival

• Registration Number: NCT02966769
• Lead Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemoradiation Group	Overall survival	Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (\>/= 60 Gy) plus Platinum-based Chemotherapy
Neoadjuvant treatment plus Surgery Group	Overall survival	Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus \>/= 45Gy) followed by Surgery

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Secondary Outcome Measures

Name	Time	Method
Mortality	5 years
Disease-free survival	5 years
Patterns of Relapse	5 years

Trial Locations

Locations (1)

Hospital Universitario Quiron Madrid; 🇪🇸 Madrid, Spain