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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

ACTRN 12619000288123

Brief Introduction

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.

Intervention/Treatment

  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Intervention: Radiation therapy
  • Drug: Avelumab

Inclusion Criteria

  1. Male/female patients aged 18 years or older.
  2. Histologically confirmed gastro-oesophageal junction or oesophageal adenocarcinoma. Oesophageal and gastroesophageal junction tumours should be TNM7 stage T1-3 and N0-N1, with no evidence of distant metastases (M0) where the MDT believes that an R0 resection can be achieved at the outset. T4 or N2 cancers are excluded as per the CROSS trial eligibility and due to the possible variable need to prolong pre-operative chemotherapy or alternate chemotherapy regimen in CRT to reduce margin involvement and improve resectability.
  3. Absence of distant metastases on CT scan and PET scan and staging laparoscopy (where indicated) prior to study entry.
  4. No prior therapy for oesophageal or GOJ adenocarcinoma.

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