<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481256</url>
  </required_header>
  <id_info>
    <org_study_id>73750</org_study_id>
    <nct_id>NCT04481256</nct_id>
    <nct_alias>NCT04595149</nct_alias>
  </id_info>
  <brief_title>TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY</brief_title>
  <acronym>TAPESTRY</acronym>
  <official_title>TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Verbeeten Insituut Tilburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Elisabeth-TweeSteden Ziekenhuis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radiotherapeutic Institute Friesland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medisch Centrum Leeuwarden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radiotherapy Group Deventer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deventer Ziekenhuis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maastro Clinic, The Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zuyderland Medisch Centrum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Isala</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ZGT</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the feasibility of treatment with bintrafusp&#xD;
      alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in&#xD;
      patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and&#xD;
      radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on&#xD;
      days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1,&#xD;
      22, and 43 at a dose of 2400 mg. External beam radiotherapy will be delivered to a total dose&#xD;
      of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the&#xD;
      first cycle of chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External 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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of toxicity</measure>
    <time_frame>36 months</time_frame>
    <description>Incidence and severity of toxicity defined according to CTCAE v5 and and Radiation Oncology Group (RTOG) criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage completion</measure>
    <time_frame>36 months</time_frame>
    <description>Percentage completion of chemotherapy and radiation treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage withdrawal rate</measure>
    <time_frame>36 months</time_frame>
    <description>Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>locoregional progression</measure>
    <time_frame>36 months</time_frame>
    <description>Infield locoregional progression free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression</measure>
    <time_frame>36 months</time_frame>
    <description>Any progression free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>36 months</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ C30))</measure>
    <time_frame>36 months</time_frame>
    <description>Overall Quality of life ranging from 0-100 with 100 being best Quality of Life with special focus on dysphagia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the number and grade of adverse events of bintrafusp alfa combined with chemoradiotherapy according to NCI common toxicity criteria (CTC) version 5</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarker</measure>
    <time_frame>54 months</time_frame>
    <description>To perform exploratory biomarker analyses for treatment response</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">49</enrollment>
  <condition>Carcinoma, Squamous Cell</condition>
  <condition>Oesophageal Cancer</condition>
  <arm_group>
    <arm_group_label>1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.&#xD;
External 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</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External beam radiotherapy</intervention_name>
    <description>External 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</description>
    <arm_group_label>1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bintrafusp alfa</intervention_name>
    <description>Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.</description>
    <arm_group_label>1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.</description>
    <arm_group_label>1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.</description>
    <arm_group_label>1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal&#xD;
             junction.&#xD;
&#xD;
          -  Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra&#xD;
             Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients&#xD;
             with M1 disease solely on the basis of supraclavicular metastasis are eligible.&#xD;
             Patients with resectable tumors refusing radical surgery are eligible.&#xD;
&#xD;
          -  Locoregional recurrences without distant metastasis after surgery alone or&#xD;
             endoscopical resection&#xD;
&#xD;
          -  Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation +&#xD;
             resection or definitive chemoradiation outside the previously irradiated area,&#xD;
             provided that full dose of radiation can safely be delivered.&#xD;
&#xD;
          -  Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible&#xD;
             if all other criteria are fulfilled.&#xD;
&#xD;
          -  If the tumor extends below the gastroesophageal (GE) junction into the proximal&#xD;
             stomach, the bulk of the tumor must involve the esophagus or GE junction.&#xD;
&#xD;
          -  Age ≥ 18.&#xD;
&#xD;
          -  ECOG performance status 0-2 (cf. Appendix A).&#xD;
&#xD;
          -  Adequate hematological, renal and hepatic functions defined as:&#xD;
&#xD;
               -  Neutrophils ≥ 1.5 x 109/L&#xD;
&#xD;
               -  Platelets ≥ 100 x 109/L&#xD;
&#xD;
               -  Hemoglobin ≥ 5.6 mmol&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x upper normal limit&#xD;
&#xD;
               -  ASAT and ALAT ≤ 1.5 x upper normal limit, Alkaline Phosphatase ≤ 2.5 x upper&#xD;
                  normal limit.&#xD;
&#xD;
               -  PT (INR) ≤ 1.5 x upper normal limit and aPTT ≤ 1.5 x upper normal limit.&#xD;
&#xD;
               -  Creatinine clearance (Cockroft) &gt; 60 ml/min&#xD;
&#xD;
          -  Written, voluntary informed consent&#xD;
&#xD;
          -  Patients must be accessible to management and follow-up in the treatment center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past or current history of malignancy other than entry diagnosis interfering with&#xD;
             prognosis of esophageal cancer.&#xD;
&#xD;
          -  Patient with tracheo-esophageal fistula or extension into the mucosal layer of the&#xD;
             trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is&#xD;
             allowed, but not through the trachea.&#xD;
&#xD;
          -  Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus&#xD;
             level.&#xD;
&#xD;
          -  Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.&#xD;
&#xD;
          -  Patient (male or female) in the reproductive age is not willing to use highly&#xD;
             effective methods of contraception (per institutional standard) during treatment and&#xD;
             for 6 months (male or female) after the end of treatment.&#xD;
&#xD;
          -  Previous chemotherapy, radiation and/or treatment with checkpoint inhibitors for the&#xD;
             currently present esophageal tumor.&#xD;
&#xD;
          -  Previous chemotherapy and/or treatment with targeted agents and/or checkpoint&#xD;
             inhibitors for other forms of cancer within the last six months.&#xD;
&#xD;
          -  Previous radiation to the mediastinum precluding full dose radiation of the currently&#xD;
             present esophageal tumor.&#xD;
&#xD;
          -  Persisting grade &gt;1 NCI CTCAE 5.0 toxicity (except alopecia and vitiligo) related to&#xD;
             prior therapy; however, grade ≤2 sensory neuropathy is acceptable.&#xD;
&#xD;
          -  Presence of an esophageal stent.&#xD;
&#xD;
          -  History of bleeding diathesis or major bleeding event (grade ≥ 2) in the month prior&#xD;
             to first dose of trial treatment.&#xD;
&#xD;
          -  Clinically significant cardiovascular disease precluding safe treatment with&#xD;
             chemoradiation.&#xD;
&#xD;
          -  Evidence of pulmonary fibrosis and/or clinically significant impairment of lung&#xD;
             function precluding safe treatment with chemoradiation. In case of doubt about&#xD;
             pulmonary function, a lung function test should be performed and, in case of&#xD;
             abnormalities, discussed with the principle investigator.&#xD;
&#xD;
          -  Serious underlying medical condition which would impair the ability of the patient to&#xD;
             receive the planned treatment, including prior allergic reactions to drugs containing&#xD;
             cremophor, such as teniposide or cyclosporine.&#xD;
&#xD;
          -  Mental status that would prohibit the understanding and giving of informed consent.&#xD;
&#xD;
          -  Inadequate caloric- and/or fluid intake despite consultation of a dietician and/or&#xD;
             tube feeding.&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive&#xD;
             drugs). Replacement therapy (e.g., thyroxine for patients with a history of&#xD;
             autoimmune-related hypothyroidism, insulin for patients with type 1 diabetes mellitus,&#xD;
             or physiologic corticosteroid replacement therapy for adrenal or pituitary&#xD;
             insufficiency, etc.) is not considered a form of systemic treatment. Patients with&#xD;
             vitiligo with dermatological manifestations only are eligible to enter the study.&#xD;
&#xD;
          -  A diagnosis of immunodeficiency or is receiving systemic steroid therapy (&gt;10 mg/day&#xD;
             prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days&#xD;
             prior to the first dose of trial treatment.&#xD;
&#xD;
          -  Diagnosis of HIV unless stable on antiretroviral therapy for at least 4 weeks, no&#xD;
             evidence of multi-drug resistance, viral load of &lt; 400 copies/ml and CD4+ T-cells ≥&#xD;
             350 cells/µl.&#xD;
&#xD;
          -  Active HBV/HCV. Participants on a stable dose of antiviral therapy with HBV/HCV viral&#xD;
             load below the limit of quantification are eligible.&#xD;
&#xD;
          -  Evidence of interstitial lung disease or active, non-infectious pneumonitis.&#xD;
&#xD;
          -  An active infection requiring systemic therapy, which has not resolved 3 days (simple&#xD;
             infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior&#xD;
             to the first dose of trial treatment.&#xD;
&#xD;
          -  Administration of a live vaccine within 30 days prior to the first dose of trial&#xD;
             treatment. Seasonal flu vaccines that do not contain a live virus are permitted.&#xD;
&#xD;
          -  Patients with prior allogeneic stem cell or solid organ transplantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanneke WM van Laarhoven, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Linde Veen</last_name>
    <phone>020-5665955</phone>
    <email>l.veen1@amsterdamumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hanneke WM van Laarhoven, MD, PhD</last_name>
    <phone>020-5665955</phone>
    <email>h.vanlaarhoven@amsterdamumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Academic Medical Center, Medical Oncology</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100 DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>H WM van Laarhoven, MD, PhD, PhD</last_name>
      <phone>31 20 5665955</phone>
      <email>h.vanlaarhoven@amc.uva.nl</email>
    </contact>
    <contact_backup>
      <last_name>Lyda ter Hofstede</last_name>
      <phone>31 20 5668229</phone>
      <email>trialmedonc@amc.uva.nl</email>
    </contact_backup>
    <investigator>
      <last_name>H. WM van Laarhoven, MD, PhD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>H.W.M. van Laarhoven</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Definitive chemoradiation</keyword>
  <keyword>TGF-beta inhibition</keyword>
  <keyword>PDL-1 ihibition</keyword>
  <keyword>feasability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481256
org study id: 73750
nct id: NCT04481256
nct alias: NCT04595149
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and
      radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on
      days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1,
      22, and 43 at a dose of 2400 mg. External 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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg. External 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.
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa
time frame: 36 months
description: 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.
measure: Incidence and severity of toxicity
time frame: 36 months
description: Incidence and severity of toxicity defined according to CTCAE v5 and and Radiation Oncology Group (RTOG) criteria.
measure: Percentage completion
time frame: 36 months
description: Percentage completion of chemotherapy and radiation treatment
measure: Percentage withdrawal rate
time frame: 36 months
description: Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications
measure: locoregional progression
time frame: 36 months
description: Infield locoregional progression free survival
measure: progression
time frame: 36 months
description: Any progression free survival
measure: Survival
time frame: 36 months
description: Overall survival
measure: Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ C30))
time frame: 36 months
description: Overall Quality of life ranging from 0-100 with 100 being best Quality of Life with special focus on dysphagia
measure: adverse events
time frame: 36 months
description: To determine the number and grade of adverse events of bintrafusp alfa combined with chemoradiotherapy according to NCI common toxicity criteria (CTC) version 5
measure: Biomarker
time frame: 54 months
description: To perform exploratory biomarker analyses for treatment response
arm group label: 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy
arm group type: Experimental
description: Non-randomized feasibility study with paclitaxel, carboplatin, bintrafusp alfa, and radiation. Paclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36. Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
External 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
intervention type: Radiation
intervention name: External beam radiotherapy
description: External 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
arm group label: 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy
intervention type: Drug
intervention name: Bintrafusp alfa
description: Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
arm group label: 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
arm group label: 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
arm group label: 1 Bintrafusp alfa, Paclitaxal, Carboplatin, Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanneke WM van Laarhoven, MD,PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Linde Veen
phone: 020-5665955
email: l.veen1@amsterdamumc.nl
last name: Hanneke WM van Laarhoven, MD, PhD
phone: 020-5665955
email: h.vanlaarhoven@amsterdamumc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: H.W.M. van Laarhoven
investigator title: Prof. dr.
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: No