Trial Status

Endorsed Studies / Open

Cancer Type

Oesophageal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

AIM

Oesophago-gastric (OG) cancers are a significant global health burden, representing the 8th most commonly diagnosed cancers. The incidence rates of distal oesophageal and gastro-oesophageal junction cancers are rising in western countries. In patients with early stage resectable disease the prognosis has been guarded with a 5-year survival rate of 33% after surgery alone. Survival advantage has been demonstrated in clinical trials with neo-adjuvant chemo-radiotherapy or perioperative platinum based chemotherapy. The potential benefits of neo-adjuvant CRT mainly are down-staging, facilitating R0 resection and treatment of micro-metastases to reduce risk of local and systemic recurrences.

The purpose of this study is to assess the safety of adding the drug avelumab to chemo-radiation using two standard chemotherapy drugs, carboplatin and paclitaxel, before surgery in patients with cancers of the oesophagus or the junction between the oesophagus and stomach (gastro-oesophageal junction). The medications used in this study are given intravenously (by vein).

Avelumab is thought to work by helping the immune system to fight against cancer cells. The purpose of this study is to determine if adding Avelumab to the chemotherapy and radiotherapy will be better. According to current standard of care chemo-radiation is given before surgery (preoperative treatment), Avelumab will be given at the same time. The main aim of this study is to determine if adding Avelumab to preoperative chemo-radiation is tolerable and more effective than preoperative chemo-radiation alone for patients with localised oesophageal and gastro-oesophageal junction cancer who are going to be treated with surgery. We will also be looking at the adverse events of this combination treatment.

PATIENTS RECRUITED

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

South Australia
Flinders Medical Centre

Trial Status

Endorsed Studies / Open

Cancer Type

Oesophageal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Protocol 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- Neo-CREATE

AIM

Immunotherapy in combination with standard neo-adjuvant chemo-radiotherapy will lead to synergism through enhanced T cell priming and boosting of cancer-immunity cycle and this will eventually improve patient outcomes. This potential synergistic drug activity will pave way to novel therapeutic strategies in patients with oesophageal and GOJ adenocarcinoma.

This study has two parts:

  • Safety run-in part: The primary objective of the safety run-in part is to evaluate the feasibility, safety and tolerability adding Avelumab to CRT in patients with operable oesophagus/ GOJ adenocarcinoma.
  • Main study part: (preliminary efficacy assessment): The primary objective of the main study part is to evaluate preliminary efficacy in terms of pCR. We aim to increase the pCR rate after neo-adjuvant treatment from 20% reported in several large trials, to a pCR rate of 40% by adding Avelumab to CRT.

To evaluate safety and efficacy in terms of the following endpoints:

  • Overall safety and tolerability as per CTCAE version 4
  • Progression free survival and overall survival
  • R0 resection rate
  • Radiological response rate using RECIST 1.1
  • Response heterogeneity in primary versus lymph nodes
  • Assess post-operative complication rate
  • QoL

PATIENTS RECRUITED

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

South Australia
Flinders Medical Centre

Principal Investigator

Dr Amitesh Roy

Detailed Information Available on

More detailed information available online at the Australian New Zealand Clinical Trial Registry (ANZCTR)