locally advanced non-small cell lung cancer (LA-NSCLC)
Conditions
Interventions
Group 1: Phase I (one arm)
- Spatially fractionated RT (SFRT) to bulky tumor as induction treatment, then 4-week break, followed by fractionated RT to residual tumor (25 x 2.4 = 60 Gy)
- SFRT will be
Sponsors
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histologically-proven NSCLC with available staging FDG-PET-CT imaging and cerebral imaging (preferably MRI) • Inoperable NSCLC stage II with positive lymph nodes (N1 – 2a) or stage III according to the Union Internationale Contre le Cancer (UICC) 9th edition • Only in trial phase I: NSCLC stage IV with oligometastatic disease, i.e. a limited number of distant metastases that are all planned to undergo ablative local treatment (e.g. RT or surgery) • Indication for definitive RT of the primary tumor and mediastinal lymph nodes, with planned sequential or simultaneous systemic treatment (e.g. sequential or simultaneous chemo- or immunotherapy) • age > 18 years of age • ECOG Score 0 – 2 (Karnofsky Performance Score > 70%)
Exclusion criteria
Exclusion criteria: • refusal of the patients to take part in the study • previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap • patients who have not yet recovered from acute toxicities of prior therapies • patients who do not qualify for sequential or simultaneous systemic treatment according to the current clinical standards (e.g. unfit for chemo- or immunotherapy) • patients with hemoptysis CTCAE = grade 2 • pregnant or lactating women • participation in another competing clinical study or observation period of competing trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: The primary endpoint is the change in the volumes of the primary tumor (GTV-T) and/or bulk lymph nodes (GTV-Nbulk) that receive SFRT from the first planning imaging (CT, MRI) to the re-evaluation, or second planning imaging, before start of fractionated RT. Phase II: The primary endpoint is progression-free survival (PFS). PFS is defined as the time from the first treatment day until the day of first occurrence of a progressive disease according to RECIST v1.1 or death of any cause. For statistical analysis and publication of the primary endpoint, the observation period extends up to one year after the end of RT (= 1 year follow-up) of the last patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint secondary endpoints of both trial phases include overall survival (OS), tumor control / relapse patterns, toxicity, patient-reported outcomes (PROM), and comprehensive biomarker analyses (circulating tumor DNA [ctDNA], immune-profiling). | — |
Countries
Germany
Contacts
Public ContactSebastian Regnery
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Outcome results
None listed