Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy

NCT05620199 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-20

No results posted yet for this study

Summary

For patients with irresectable locally advanced non-small cell lung cancer (NSCLC) (e.g. multilevel or bulky N2 disease or presence of N3 lymph node metastases), current guidelines recommend treatment with chemoradiotherapy (CRT) followed by immune checkpoint inhibition (ICI, durvalumab). Chances of sterilization of a large (e.g. clinically staged T3 or T4 tumor) tumor volume by CRT alone are relatively small and these tumors are associated with a high local recurrence rate. Moreover, necrosis and cavitation of these tumors puts these patients at risk of fatal bleeding and might cause infectious complications, which lead to subsequent impaired quality of life (QoL) and to interruption of, or the need for postponing, (systemic) treatment.

Upfront resection of the tumor in the lung, followed by postoperative CRT in patients who have a (potentially) resectable tumor could be a strategy to prevent complications of CRT in large volume and/or cavitating tumors with extensive mediastinal disease.

Conditions

  • Locally Advanced Non-Small Cell Lung Cancer
  • Chemoradiotherapy
  • Cavitation Lung
  • Surgery
  • Feasibility
  • Safety

Interventions

PROCEDURE

Upfront resection

Resection of the primary tumor

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER
  • Radboud University Medical Center

    collaborator OTHER
  • University Medical Center Groningen

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • Maastricht University Medical Center

    collaborator OTHER
  • Zuyderland Medical Centre

    collaborator OTHER
  • Maxima Medical Center

    collaborator OTHER
  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Koen Hartemink, MD, PhD · The Neterlands Cancer Institute (NKI), Antoni van Leeuwenhoek

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-04-01
Completion
2025-04-01

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620199 on ClinicalTrials.gov