The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with esophageal cancer that is locally advanced or has spread to another area of the body (metastasized).
Males and females > 18 years of age.
Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-oesophageal junction
Oligometastatic disease (1-5 lesions outside the primary tumour radiotherapy field on FDG-PET scan), or locoregionally advanced disease unsuitable for either surgical resection or radical chemoradiotherapy
Symptomatic dysphagia (Mellow score greater than 0)
Bulky or organ-threatening metastatic disease requiring upfront higher dose chemotherapy in the judgement of the treating clinician.
Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation) if oligometastatic disease.
Previous systemic therapy for oesophageal or GOJ carcinoma.
Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases is permitted.
Single group
Durvalumab
DrugDurvalumab will be supplied by AstraZeneca as a 500 mg vial concentrate for solution for infusion. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine-hydrochloride, 275 mM trehalose dihydrate, and 0.02% weight/volume (w/v) polysorbate 80; it has a pH of 6.0 and density of 1.054 g/mL. The label-claim volume is 10 mL. Durvalumab is a sterile, clear to opalescent, colorless to slightly yellow solution, free from visible particles. Investigational product vials are stored at 2°C to 8°C and must not be frozen. Investigational product must be kept in original packaging until use to prevent prolonged light exposure.
Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT scan and clinical review.
The interval from the date of participant registration to the date of a progression free survival event: 1. date of the first CT scan to show disease progression 2. patient is judged to have progressed by the responsible investigator (in the event that no RECIST assessment is available) 3. death occurs.
Duration of dysphagia relief
Maintenance of Mellow score at least 1 point above baseline. Mellow score may be optionally assessed at days 22, 36 and 50 if the participants attend the clinic for any other unscheduled visit. Mellow score ranges from grade 0-4. Grade 0 indicating no dysphagia and grade 4 indicating inability to swallow.
Nutritional status
Determined by clinical review and collected from the participant using the scored Patient-generated subjective global assessment (PG\_SGA) tool.
Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30
Assessment of European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30
Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18
Assessment of European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18
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