Neo-CREATE

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.

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

Alison Richards (alison.richards@sa.gov.au) and Aleksandra Kuruni (Aleksandra.kuruni@sa.gov.au)

Study Chair

Associate Professor Amitesh Roy

DETAILED INFORMATION AVAILABLE

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

Funding

Merck