protocolSection identificationModule nctId: NCT06328361, orgStudyIdInfo id: R24008, briefTitle: Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer, acronym: NORPPA-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2032-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Tampere University Hospital, class: OTHER, collaborators name: Tampere University, collaborators name: Helsinki University Central Hospital, collaborators name: Turku University Hospital, collaborators name: Kuopio University Hospital, collaborators name: Oulu University Hospital, collaborators name: Jyväskylä Central Hospital, collaborators name: Seinajoki Central Hospital, collaborators name: Satakunta Central Hospital, collaborators name: North Karelia Central Hospital, collaborators name: Tartu University Hospital, collaborators name: East Tallinn Central Hospital, collaborators name: West Tallinn Central Hospital, collaborators name: North Estonia Medical Centre, descriptionModule briefSummary: The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are* if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere* what is the organ preservation rate* what is the local regrowth rate, conditionsModule conditions: Rectal Cancer, conditions: Rectal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Nonoperative surveillance, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: TME-free survival, secondaryOutcomes measure: ctDNA-free survival, secondaryOutcomes measure: Post local regrowth disease-free survival, secondaryOutcomes measure: Post local regrowth overall survival, secondaryOutcomes measure: Local regrowth-free survival, secondaryOutcomes measure: Local recurrence-free survival, secondaryOutcomes measure: Distant metastases-free survival, secondaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Salvage rate after local regrowth, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Complication rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: East Tallinn Central Hospital, city: Tallinn, country: Estonia, geoPoint lat: 59.43696, lon: 24.75353, locations facility: North Estonia Medical Centre, city: Tallin, country: Estonia, contacts name: Indrek Seire, MD, PhD, role: CONTACT, email: indrek.seire@ut.ee, geoPoint lat: 59.43696, lon: 24.75353, locations facility: West Tallinn Central Hospital, city: Tallin, country: Estonia, contacts name: Kaur Liivak, MD, PhD, role: CONTACT, email: kaur.liivak@keskhaigla.ee, geoPoint lat: 59.43696, lon: 24.75353, locations facility: Tartu University Hospital, city: Tartu, country: Estonia, contacts name: Jaan Soplepman, MD, PhD, role: CONTACT, email: jaan.soplepmann@kliinikum.ee, geoPoint lat: 58.38062, lon: 26.72509, locations facility: Helsinki University Central Hospital, city: Helsinki, zip: 00290, country: Finland, contacts name: Anna H Lepistö, MD, PhD, role: CONTACT, email: anna.lepisto@hus.fi, geoPoint lat: 60.16952, lon: 24.93545, locations facility: North Karelia Central Hospital, city: Joensuu, country: Finland, contacts name: Markku Matikainen, MD, PhD, role: CONTACT, email: markku.matikainen@siunsote.fi,, geoPoint lat: 62.60118, lon: 29.76316, locations facility: Jyväskylä Central Hospital, city: Jyväskylä, country: Finland, contacts name: Kyösti Tahkola, MD, PhD, role: CONTACT, email: kyosti.tahkola@hyvaks.fi, geoPoint lat: 62.24147, lon: 25.72088, locations facility: Kuopio University Hospital, city: Kuopio, country: Finland, contacts name: Anne Fageström, MD, PhD, role: CONTACT, email: anne.fagerstrom@pshyvinvointialue.fi, geoPoint lat: 62.89238, lon: 27.67703, locations facility: Oulu University Hospital, city: Oulu, country: Finland, contacts name: Karoliina Paarmio, MD, PhD, role: CONTACT, email: karoliina.paarnio@pohde.fi, geoPoint lat: 65.01236, lon: 25.46816, locations facility: Satakunta Central Hospital, city: Pori, country: Finland, contacts name: Jyrki Haikonen, MD, PhD, role: CONTACT, email: jyrki.haikonen@sata.fi, geoPoint lat: 61.48333, lon: 21.78333, locations facility: Seinajoki Central Hospital, city: Seinäjoki, country: Finland, geoPoint lat: 62.79446, lon: 22.82822, locations facility: Tampere University Hospital, city: Tampere, zip: 33400, country: Finland, contacts name: Toni T Seppälä, MD, PhD, role: CONTACT, phone: +358444722846, email: toni.seppala@tuni.fi, geoPoint lat: 61.49911, lon: 23.78712, locations facility: Turku University Hospital, city: Turku, country: Finland, contacts name: Pirita Varpe, MD, PhD, role: CONTACT, email: Pirita.Varpe@tyks.fi, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False