protocolSection identificationModule nctId: NCT06290505, orgStudyIdInfo id: PALEO, briefTitle: A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study, acronym: PALEO, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-08, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Australasian Gastro-Intestinal Trials Group, class: NETWORK, descriptionModule briefSummary: 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 oesophageal cancer that has spread to another are of the body (metastasised)., conditionsModule conditions: Oesophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Durvalumab, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: Duration of dysphagia relief, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30, secondaryOutcomes measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18, secondaryOutcomes measure: Response rate in metastatic lesions, secondaryOutcomes measure: Physician graded toxicity, secondaryOutcomes measure: SAE Rate, secondaryOutcomes measure: Overall survival., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Border Medical Oncology, status: RECRUITING, city: Albury, state: New South Wales, zip: 2640, country: Australia, contacts name: Jacqui McBurnie, role: CONTACT, email: jacqui.mcburnie@bordermedonc.com.au, geoPoint lat: -36.07482, lon: 146.92401, locations facility: Calvary Mater Newcastle, status: RECRUITING, city: Newcastle, state: New South Wales, zip: 2298, country: Australia, contacts name: Kim Adler, role: CONTACT, email: paleo@calvarymater.org.au, geoPoint lat: -32.92715, lon: 151.77647, locations facility: Royal Brisbane and Women's Hospital, status: RECRUITING, city: Herston, state: Queensland, zip: 4029, country: Australia, contacts name: Jacqui Keller, role: CONTACT, email: jacqui.keller@health.qld.gov.au, geoPoint lat: -27.44453, lon: 153.01852, locations facility: Flinders Medical Centre, status: RECRUITING, city: Bedford Park, state: South Australia, country: Australia, contacts name: Aleksandra Kuruni, Dr, role: CONTACT, email: Aleksandra.Kuruni@sa.gov.au, geoPoint lat: -35.03333, lon: 138.56667, locations facility: St Vincent's Hospital, status: RECRUITING, city: Fitzroy, state: Victoria, zip: 3065, country: Australia, contacts name: Nadia Ranieri, role: CONTACT, email: Nadia.RANIERI@svha.org.au, geoPoint lat: -37.79839, lon: 144.97833, locations facility: Peter MacCallum Cancer Centre, status: RECRUITING, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Shandelle Norman, role: CONTACT, email: Shandelle.Norman@ctaust.org, geoPoint lat: -37.814, lon: 144.96332, locations facility: Sir Charles Gairdner Hospital, status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Aylin Yahya, role: CONTACT, email: Aylin.Yahya@health.wa.gov.au, geoPoint lat: -31.98184, lon: 115.8073, locations facility: Auckland Hospital, status: RECRUITING, city: Grafton, state: Auckland, zip: 1023, country: New Zealand, contacts name: Sophie Goodger, role: CONTACT, email: SophieGo@adhb.govt.nz, geoPoint lat: -36.86029, lon: 174.76566, hasResults: False