T1-T2N0 esophageal adenocarcinoma including gastroesophageal junction (GEJ) with indication for radical surgery
Conditions
Brief summary
Rate of clinical and pathological complete response rate at time of endoscopic re-evaluation (at the end of the core study treatment) according to Becker criteria and investigator-based RECIST v1.1 assessment as well as endoscopic response criteria similar to the Japanese Gastric Cancer Association Guideline
Detailed description
Rate of cCR/pCR at 1, 2 and 3 years after start of treatment (long term follow up), Subgroup analysis of cCR/pCR rate at time of endoscopic re-evaluation and after 1 year according to following characteristics: MSI high, PD-L1 CPS>1 and PD-L1 CPS>5 and especially acc. to CPS ≥10 or <10, Rate of salvage surgery, 90-day as well as 1-year mortality after start of treatment in nonsurgery population and population with salvage surgery, Determination of the sites of tumor relapse, Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), Severity of adverse events by CTCAE v5.0 grade, Relationship of adverse events to the durvalumab, chemotherapy and/or radiation, Frequency of clinically significant abnormal laboratory parameters, Assessment of quality of life (QoL) data from patients using EORTC QLQC30 and the esophageal module OES18
Interventions
DRUGmedoxa 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGInjektionslösung
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical and pathological complete response rate at time of endoscopic re-evaluation (at the end of the core study treatment) according to Becker criteria and investigator-based RECIST v1.1 assessment as well as endoscopic response criteria similar to the Japanese Gastric Cancer Association Guideline | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of cCR/pCR at 1, 2 and 3 years after start of treatment (long term follow up), Subgroup analysis of cCR/pCR rate at time of endoscopic re-evaluation and after 1 year according to following characteristics: MSI high, PD-L1 CPS>1 and PD-L1 CPS>5 and especially acc. to CPS ≥10 or <10, Rate of salvage surgery, 90-day as well as 1-year mortality after start of treatment in nonsurgery population and population with salvage surgery, Determination of the sites of tumor relapse, Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), Severity of adverse events by CTCAE v5.0 grade, Relationship of adverse events to the durvalumab, chemotherapy and/or radiation, Frequency of clinically significant abnormal laboratory parameters, Assessment of quality of life (QoL) data from patients using EORTC QLQC30 and the esophageal module OES18 | — |
Countries
Germany
Outcome results
None listed