Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 9:02 PM
Study NCT ID:
NCT06328361
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-03-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009926', 'term': 'Organ Preservation'}], 'ancestors': [{'id': 'D014021', 'term': 'Tissue Preservation'}, {'id': 'D011309', 'term': 'Preservation, Biological'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '2 years', 'description': 'Survival from complete clinical response to locoregional failure or distant metastases'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to death or censoring of observation'}, {'measure': 'TME-free survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to total mesorectal excision surgery'}, {'measure': 'ctDNA-free survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to positive ctDNA result'}, {'measure': 'Post local regrowth disease-free survival', 'timeFrame': '5 years', 'description': 'Survival from operated local regrowth to recurrence'}, {'measure': 'Post local regrowth overall survival', 'timeFrame': '5 years', 'description': 'Survival from operated local regrowth to death or censoring of observation'}, {'measure': 'Local regrowth-free survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to local regrowth'}, {'measure': 'Local recurrence-free survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to local recurrence after local regrowth'}, {'measure': 'Distant metastases-free survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to distant metastases'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'Survival from complete clinical response to locoregional failure or distant metastases'}, {'measure': 'Salvage rate after local regrowth', 'timeFrame': '5 years', 'description': 'Rate of successful TME surgery, local excision or metastasectomy after local regrowth'}, {'measure': 'Quality of life score', 'timeFrame': '5 years', 'description': 'Baseline and change in quality of life after complete clinical response'}, {'measure': 'Complication rates', 'timeFrame': '5 years', 'description': 'Clavien-Dindo complications after NOM and after local regrowth and after recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer', 'Rectal Adenocarcinoma']}, '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\n\n* if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere\n* what is the organ preservation rate\n* what is the local regrowth rate', 'detailedDescription': "Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response.\n\nObjective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences.\n\nDesign: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM.\n\nPrimary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM.\n\nSecondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years.\n\nInclusion Criteria: Patients must have histopathologically confirmed primary rectal adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR) after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment after considering the risk of recurrence.\n\nExclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18, those not receiving neoadjuvant treatment, or those unable to provide informed consent are excluded.\n\nDiagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with clinical examination, laboratory tests, and imaging.\n\nRandomization: No randomization is performed.\n\nFollow-up: Patients are monitored every 3 months for the first 2 years, then every 6 months for 3 years. Monitoring replaces surgical intervention unless cancer recurs. Follow-up is part of standard care, with costs covered by the healthcare system.\n\nSafety: Incidence of local recurrence and success of resection post-recurrence are monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study termination at the center.\n\nData Collection: Clinical data are entered into electronic case report forms (eCRFs) based on primary healthcare documentation and stored pseudonymized on the primary research center's server. Molecular and pseudonymized clinical data are collected securely for analysis.\n\nSample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated to provide sufficient data for the primary and key secondary endpoints and to meet other study objectives accurately.\n\nData Handling: Data handling adheres to privacy legislation, with information stored pseudonymously."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathological verification of primary rectal adenocarcinoma\n* Complete clinical response at response assessment after neoadjuvant therapy\n* Informed consent to organ preservation study\n\nExclusion Criteria:\n\n* Evidence of metastatic disease (fulfilling M-class criteria of TNM)\n* No neoadjuvant therapy\n* Inability to understand the information related to harms and benefits'}, 'identificationModule': {'nctId': 'NCT06328361', 'acronym': 'NORPPA-1', 'briefTitle': 'Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Nordic ORgan Preservation Pilot Approach - A Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer (NORPPA-1)', 'orgStudyIdInfo': {'id': 'R24008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nonoperative management', 'description': 'The patients presenting with complete clinical response undergo nonoperative management (i.e. watch \\& wait) as surveillance for local regrowth or distant spread.', 'interventionNames': ['Procedure: Nonoperative surveillance']}], 'interventions': [{'name': 'Nonoperative surveillance', 'type': 'PROCEDURE', 'otherNames': ['Watch and Wait', 'Organ preservation'], 'description': 'Clinical and imaging surveillance with digital rectal examination and/or endoscopy, rectal MRI and body CT', 'armGroupLabels': ['Nonoperative management']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tallinn', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Mihkel Mettis, MD, PhD', 'role': 'CONTACT', 'email': 'mihkel.mettis@itk.ee'}], 'facility': 'East Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Indrek Seire, MD, PhD', 'role': 'CONTACT', 'email': 'indrek.seire@ut.ee'}], 'facility': 'North Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Kaur Liivak, MD, PhD', 'role': 'CONTACT', 'email': 'kaur.liivak@keskhaigla.ee'}], 'facility': 'West Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Jaan Soplepman, MD, PhD', 'role': 'CONTACT', 'email': 'jaan.soplepmann@kliinikum.ee'}], 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '00290', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Anna H Lepistö, MD, PhD', 'role': 'CONTACT', 'email': 'anna.lepisto@hus.fi'}], 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Jyväskylä', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Kyösti Tahkola, MD, PhD', 'role': 'CONTACT', 'email': 'kyosti.tahkola@hyvaks.fi'}], 'facility': 'Jyväskylä Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Anne Fageström, MD, PhD', 'role': 'CONTACT', 'email': 'anne.fagerstrom@pshyvinvointialue.fi'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Karoliina Paarmio, MD, PhD', 'role': 'CONTACT', 'email': 'karoliina.paarnio@pohde.fi'}], 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Pori', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jyrki Haikonen, MD, PhD', 'role': 'CONTACT', 'email': 'jyrki.haikonen@sata.fi'}], 'facility': 'Satakunta Central Hospital', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'city': 'Seinäjoki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Ismo Laitinen, MD, PhD', 'role': 'CONTACT', 'email': 'ismo.laitinen@hyvaep.fi'}], 'facility': 'Seinajoki Central Hospital', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '33400', 'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Toni T Seppälä, MD, PhD', 'role': 'CONTACT', 'email': 'toni.seppala@tuni.fi', 'phone': '+358444722846'}], 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pirita Varpe, MD, PhD', 'role': 'CONTACT', 'email': 'Pirita.Varpe@tyks.fi'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '65100', 'city': 'Vaasa', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jan Andersen, MD, PhD', 'role': 'CONTACT', 'email': 'jan.andersen@ovph.fi', 'phone': '358 6 2181111'}, {'name': 'Jan Andersen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vaasa Central Hospital', 'geoPoint': {'lat': 63.096, 'lon': 21.61577}}], 'centralContacts': [{'name': 'Toni T Seppälä, MD, PhD', 'role': 'CONTACT', 'email': 'toni.seppala@tuni.fi', 'phone': '+358444722846'}], 'overallOfficials': [{'name': 'Toni T Seppälä, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The European Data Protection Regulation (GDPR) does not allow sharing other than anonymised patient level data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}, {'name': 'Seinajoki Central Hospital', 'class': 'OTHER'}, {'name': 'Satakunta Central Hospital', 'class': 'OTHER'}, {'name': 'North Karelia Central Hospital', 'class': 'OTHER'}, {'name': 'Tartu University Hospital', 'class': 'OTHER'}, {'name': 'East Tallinn Central Hospital', 'class': 'OTHER'}, {'name': 'West Tallinn Central Hospital', 'class': 'UNKNOWN'}, {'name': 'North Estonia Medical Centre', 'class': 'OTHER'}, {'name': 'Vaasa Central Hospital, Vaasa, Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}