• Neo-CREATE

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.

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

Purpose of the Study

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.

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.

Primary Endpoint

  • Assess safety of the chemo-radiotherapy- immunotherapy combination in patients with operable oesophageal and Gastroeosophageal Junction adenocarcinoma.
  • Assess efficacy in terms of pathological complete response (pCR) for the overall study.

Secondary Endpoint

To assess the safety and tolerability profile of neo-adjuvant CRT-Av in patients with potentially operable oesophageal and GOJ adenocarcinoma as per CTCAE version 4.

Eligibility Criteria

Inclusion Criteria

  • Male/female patients aged 18 years or older
  • Histologically confirmed gastro-oesophageal junction or oesophageal adenocarcinoma.
  • Absence of distant metastases on CT scan and PET scan and staging laparoscopy (where indicated) prior to study entry.
  • No prior therapy for oesophageal or GOJ adenocarcinoma

Exclusion Criteria

  • Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of carboplatin or paclitaxel.
  • Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma.
  • Patients who have received immunotherapy for a previous malignancy.
  • Any previous malignancy, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
  • Any other histology apart from adenocarcinoma are excluded
  • Any previous malignancy where patient has had less than or equal to 5 years of a disease free period. If patient has had greater than or equal to 5 years disease free period and where patient is deemed cured, patient may be eligible subject to Chief principle investigator decision.

Contact Email

TBC

DETAILED INFORMATION AVAILABLE ON

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

PRINCIPAL INVESTIGATOR

Dr Amitesh Roy

Patients Recruited

Click here 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)