N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966769
• Other study ID #: GICOR -SEOR 5-16
• Status: Completed
• Phase: N/A
• First received: November 11, 2016
• Last updated: February 15, 2018
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: Grupo de Investigación Clínica en Oncología Radioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chemoradiation
• Lung Neoplasms
• Non-small-Cell Lung Carcinoma
• Stage IIIA-N2
• Surgery
• Survival

Intervention

Other:
• Overall survival
Compare overall survival between both groups.

Locations

Country	Name	City	State
Spain	Hospital Universitario Quiron Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Investigación Clínica en Oncología Radioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years
Secondary	Disease-free survival		5 years
Secondary	Patterns of Relapse		5 years
Secondary	Mortality		5 years