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  • NEOCREATE

    Acronym: 

    NEOCREATE

    ACTRN/NCT /ethics: 

    ACTRN12619000288123

    Scientific title: 

    Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

    Summary of trial and patient characteristics

    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase II Tumour Stream Gastro-Oesophageal Cancers
    Age Range 18 years and older Cancer Stage Early/In Situ
    Sex Both Anticipated Start Date 2019-05-31
    Molecular Target Anticipated End Date
    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Gastro-Oesophageal Cancers
    Cancer Stage Early/In Situ
    Anticipated Start Date 2019-05-31
    Anticipated End Date

    Trial Summary

    This study aims to evaluate the safety and preliminary efficacy of a drug called Avelumab in combination with chemotherapy plus radiotherapy (CRT) in patients with resectable oesophageal/ gastro-oesophageal junction (GOJ) adenocarcinoma. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of early or local gastro-oesophageal junction or oesophageal adenocarcinoma. Study details All participants in this study will receive the drug Avelumab in addition to chemoradiotherapy (CRT). Patients will receive 5 weeks of carboplatin-paclitaxel-Radiotherapy. Avelumab will be given as intravenous infusion at the dose of 10mg/kg over 60 minutes in 250mL Sodium Chloride 0.9% every 2 weeks concurrently with CRT and then for 2 more cycles (total 5 cycles of Avelumab; 3 concurrently and 2 cycles as single agent) pre surgery. Surgery will be carried out 6-8 weeks post completion of the CRT component. After surgery patients will then be followed up every 3 months for 2 years then 6 monthly for one year. Standard of care imaging results will be collected as well as blood tests. It is hoped that this research will show support for improved patient outcomes by using an immunotherapy.

    Lay Summary

    Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

    Sponsor / Cooperative group

    SA HEALTH

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Amitesh Roy Recruiting