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Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option
Rekrutierend
NCT-Nummer:
NCT04926584
Studienbeginn:
Dezember 2017
Letztes Update:
16.08.2022
Wirkstoff:
induction therapy
Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Klinikum Esslingen
Collaborator:
-
Kontakt
Martin Faehling, MD, MSc
Kontakt:
Phone: +49711310382411
E-Mail: m.faehling@klinikum-esslingen.de» Kontaktdaten anzeigen
Detailed Description:
In a certified lung- cancer center, patients with NSCLC and a potentially curative stage
(including patients with oligometastatic disease) are prospectively enrolled if curative
treatment (either definitive radio-chemotherapy or resection) cannot be performed due to
large tumor size or for functional reasons (e. g. too large radiation field or functionally
inoperable for the required resection). For these patients, the multidisciplinary tumor board
(MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically
including PET-CT if indicated. After review of the MDB, patients receive either definitive
curative treatment or palliative treatment.
Inclusion Criteria:
- newly diagnosed NSCLC
- histologically or cytologically proven
- stage III - IVA (oligometastatic) by complete staging
- ECOG 0-2
- life expectancy 3 months
- ability to provide written informed consent
Exclusion Criteria:
- primary resectability
- primary definitive chemoradiotherapy feasible
Primary outcome:
1. patients completing definitive therapy (Time Frame - 1 year):
proportion of patients completing definitive therapy
Secondary outcome:
1. complete or partial radiologic response (Time Frame - 1 year):
proportion of patients who achieved complete or partial radiologic response
2. local downstaging (Time Frame - 1 year):
proportion who achieved local downstaging
3. complete metabolic response (Time Frame - 1 year):
proportion who achieved complete metabolic response
4. overall survival (OS) (Time Frame - 5 years):
overall survival (OS)
5. event-free survival (EFS) (Time Frame - 5 years):
event-free survival (EFS)
- induction therapy:
induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy
Quelle: ClinicalTrials.gov
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