protocolSection identificationModule nctId: NCT06345079, orgStudyIdInfo id: AG0219NET, briefTitle: Cessation of Somatostatin Analogues After PRRT in Mid-Gut Neuroendocrine Tumours, acronym: STOPNET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Australasian Gastro-Intestinal Trials Group, class: NETWORK, collaborators name: Canadian Cancer Trials Group, descriptionModule briefSummary: Neuroendocrine tumours (NETs) are slow growing cancers, which commonly present as metastatic incurable disease. Some neuroendocrine tumours, termed functional NETs, overproduce hormones which result in a variety of symptoms. However, approximately 75% of NETs are considered non-functional meaning that they do not result in hormone overproduction. The main treatment for both functional and non-functional NETs is somatostatin analogues (SSA, a type of inhibitory hormone). These drugs slow tumour growth and reduce hormone production. Over time, the majority of patients will experience tumour growth despite treatment with SSA therapy. When this occurs, the addition of Peptide Receptor Radionuclide Therapy (PRRT, a type of targeted radiotherapy) in combination with ongoing SSA therapy is given. However, it is not known if continuing SSA therapy after commencement of PRRT is beneficial or not.The aim of this study is to estimate the outcomes of patients with grade 1 and 2 well differentiated mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA., conditionsModule conditions: Neuroendocrine Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Cessation of somatostatin analogues, interventions name: Continuation of somatostatin analogues, outcomesModule primaryOutcomes measure: 20-month progression free survival rate after PRRT, primaryOutcomes measure: Assess the barriers which would impede the feasibility of a subsequent phase 3 trial, secondaryOutcomes measure: Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales, secondaryOutcomes measure: Measure Quality of life using the EORTC QLQ-GINET21 scales, secondaryOutcomes measure: Cost-effectiveness of SSA therapy cessation, secondaryOutcomes measure: Psycho-oncological impacts of SSA therapy cessation: Decision Regret, secondaryOutcomes measure: Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression, secondaryOutcomes measure: Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict, secondaryOutcomes measure: Time to commencement of subsequent therapy, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Rates of SSA being recommenced over time, otherOutcomes measure: Exploratory analyses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Brisbane Women's Hospital, city: Brisbane, state: Queensland, zip: 4006, country: Australia, contacts name: Matthew Burge, role: CONTACT, phone: (07) 3636 8111, email: Matthew.Burge@health.qld.gov.au, contacts name: Matthew Burge, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False