Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
This is a non-randomised trial with one experimental arm, designed to assess the safety of chemo-radiotherapy-immunotherapy combination in patients with operable oesophageal and gastroeosophageal junction cancer. All participants will receive 5 weeks of weekly 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 chemoradiotherapy. A further two doses of 2 weekly avelumab will then be given alone.
Conditions
This trial is treating people with oesophageal and gastroeosophageal junction cancer
Eligibility
Inclusion
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
Exclusion
1. Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of carboplatin or paclitaxel.
2. Known severe hypersensitivity reactions to monoclonal antibodies (Grade equal to or greater than 3 NCI CTCAE v4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partially controlled asthma).
3. Patients who have received immunotherapy for a previous malignancy.
4. Any previous malignancy, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
5. Any other histology apart from adenocarcinoma are excluded
6. 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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Merck
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
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