The primary objective of this study is to assess the feasibility of treatment with bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.
Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal junction.
Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients with M1 disease solely on the basis of supraclavicular metastasis are eligible. Patients with resectable tumors refusing radical surgery are eligible.
Locoregional recurrences without distant metastasis after surgery alone or endoscopical resection
Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation + resection or definitive chemoradiation outside the previously irradiated area, provided that full dose of radiation can safely be delivered.
Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
Patient with tracheo-esophageal fistula or extension into the mucosal layer of the trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is allowed, but not through the trachea.
Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus level.
Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
Single group
External beam radiotherapy
RadiationExternal beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy
Bintrafusp alfa
DrugBintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
Paclitaxel
DrugPaclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
Carboplatin
DrugCarboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa
The primary outcome of this study is the percentage of patients that completes at least two cycles of bintrafusp alfa together with their chemoradiotherapy regimen.
Incidence and severity of toxicity
Incidence and severity of toxicity defined according to CTCAE v5 and and Radiation Oncology Group (RTOG) criteria.
Percentage completion
Percentage completion of chemotherapy and radiation treatment
Percentage withdrawal rate
Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications
locoregional progression
Infield locoregional progression free survival
Biomarker
To perform exploratory biomarker analyses for treatment response
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
UMC Utrecht
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Institute Verbeeten
Collaborator
Elisabeth-TweeSteden Ziekenhuis
Collaborator
Leiden University Medical Center
Collaborator
Radiotherapeutic Institute Friesland
Collaborator
Frisius Medisch Centrum
Collaborator
Radiotherapy Group Deventer
Collaborator
Deventer Ziekenhuis
Collaborator
Rijnstate Hospital
Collaborator
Erasmus Medical Center
Collaborator
The Netherlands Cancer Institute
Collaborator
Isala
Collaborator
University Medical Center Groningen
Collaborator
Ziekenhuisgroep Twente
Collaborator
