N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

Grupo de Investigación Clínica en Oncología Radioterapia

Status: Completed

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

Treatments: Other: Overall survival

Study type: Observational

Funder types: Other

Identifiers

NCT02966769

GICOR -SEOR 5-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

294 participants in 2 patient groups

Chemoradiation Group

Description:

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

Treatment:

Other: Overall survival

Neoadjuvant treatment plus Surgery Group

Description:

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

Treatment:

Other: Overall survival