Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy
NCT05620199 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-03-20
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 - 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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