Brief Summary
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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells and radiation treatment regimen in people with esophageal cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs that is locally advancedat a late stage, far along or has spread to another area of the body (metastasized).
Intervention / Treatment
- Drug: Durvalumab
Inclusion Criteria:
- Males and females > 18 years of age.
- Biopsyremoval of a section of tissue to analyse for cancer cells proven adenocarcinomacancer arising from mucus-producing glands in organs or squamous cell carcinomacancer arising from tissues that line organs of the esophagus or gastro-oesophageal junctionthe area where the oesophagus and the stomach meet
- Oligometastatic disease (1-5 lesions outside the primary tumoura tissue mass that forms from groups of unhealthy cells radiotherapy field on FDG-PET scan), or locoregionally advanced disease unsuitable for either surgical resectionsurgical removal of tissue or part/all of an organ or radical chemoradiotherapy
- Symptomatic dysphagia (Mellow score greater than 0)
- ECOG performance status 0-2
- Anticipated life expectancy of greater than 12 weeks.
- Body weight of greater than 30kg.
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells function, with values within the ranges specified below. Bloodthe red bodily fluid that transports oxygen and other nutrients around the body transfusions are permissible.
- White blood cell count greater than or equal to 2 x (10 to the power of 9)/L
- Absolute neutrophil count greater than or equal to 1.5 x (10 to the power of 9)/L
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding greater than or equal to 100 x (10 to the power of 9)/L
- Haemoglobin greater than or equal to 90g/L
- Adequate liver function, with values within the ranges specified below:
- Alanine transferase less than or equal to 2.5 x upper limit of normal (ULN)
- Aspartate transferase less than or equal to 2.5 x ULN
- Total bilirubin less than or equal to 1.5 x ULN (except patients with Gilbert’s Syndrome, who can have total bilirubin less than or equal to 5 x ULN)
- Adequate renal function, with values within the ranges specified below. Note that an estimated renal function of greater than 125mL/min by the Cockroft-Gault formula must not be used for carboplatin dosing, and must instead be determined using a direct method.
- Serum creatinine less than or equal to 1.5 x ULN
- Creatinine clearance (CrCl) greater than or equal to 40 mL/min using Cockroft-Gault formula
- Tumour tissuea group of cells that work together to perform a function (formalin-fixed, paraffin embedded) should be available for PD-L1 and mismatch repair (MMR) protein expression and can be provided as a block or slides (archival tissue is acceptable). Blocks prepared from cytological samples, where tumour cell number is sufficient, are also acceptable. Patients will not be selected by PD-L1 or MMR status.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Signed, written and informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..