None listed
Conditions
Brief summary
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. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of early or local gastro-oesophageal junction or oesophageal adenocarcinoma. Study details All participants in this study will receive the drug Avelumab in addition to chemoradiotherapy (CRT). Patients will receive 5 weeks of 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 CRT and then for 2 more cycles (total 5 cycles of Avelumab; 3 concurrently and 2 cycles as single agent) pre surgery. Surgery will be carried out 6-8 weeks post completion of the CRT component. After surgery patients will then be followed up every 3 months for 2 years then 6 monthly for one year. Standard of care imaging results will be collected as well as blood tests. It is hoped that this research will show support for improved patient outcomes by using an immunotherapy.
Interventions
Addition of Avelumab to chemoradiotherapy prior to surgery.
Patients 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. Total of 5 cycles of Avelumab.
Sponsors
Southern Adelaide Local Health Network Inc
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
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.
Outcome results
None listed