eoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy
- Conditions
- Cancer - Oesophageal (gullet)gastro-oesophageal junction cancerOesophageal cancer
- Registration Number
- ACTRN12619000288123
- Lead Sponsor
- Southern Adelaide Local Health Network Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess safety of the chemo-radiotherapy- immunotherapy combination in patients with operable oesophageal and Gastroeosophageal Junction adenocarcinoma. Measured by looking at the rates of any grade 3 or 4 toxicities.<br>Some of the common adverse events seen using the interventions on this trial are fatigue, nausea, vomiting, rash, decrease in blood counts, diarrhoea, constipation, allergic reactions and immune related reactions (such as inflammation of tissues).<br>These will be assessed through physical examinations.[3 years post treatment.];Assess efficacy in terms of pathological complete response (pCR) for the overall study.<br><br>This will be determined post surgery by the analysis of the specimen resected. [At time of surgery];Assess feasibility of the chemo-RT- immunotherapy combination in patients with operable oesophageal and GOJ adenocarcinoma. <br>This will be measured through the treatment being delivered per protocol[3 years post treatment]
- Secondary Outcome Measures
Name Time Method 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.<br>This will be an ongoing review of safety data and any dose limiting toxicities observed,<br>[The first timepoint is 10 patients completing chemoradiotherapy and avelumab with or without surgery.<br>The second timepoint will be when a further 5 patients reached surgery.<br>A final analysis will occur when all data is received for all patients, expected to be 3 years post last patient undergoing surgery]