Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-13 @ 10:47 PM
Study NCT ID:
NCT05524012
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* histological analysis of tumor specimens (pre-treatment biopsy and resected tumor)\n* blood samples (Circulating Tumor Cells, CTCs)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor regression grading (TRG)', 'timeFrame': 'after completion of neoadjuvant treatment (up to 10 months)', 'description': 'Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;'}], 'secondaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'up to 10 months, until resection', 'description': 'longitudinal changes in multiparametric MRI sequences (diffusion weighted and hypoxia sensitive)'}, {'measure': 'Circulating Tumor Cells (CTC)', 'timeFrame': '5 years', 'description': 'longitudinal changes in CTCs'}, {'measure': 'Tumor Infiltrating Lymphocytes (TIL)', 'timeFrame': 'up to 10 months, until resection', 'description': 'longitudinal changes in TILs'}, {'measure': 'PFS', 'timeFrame': '5 years', 'description': 'progression free survival'}, {'measure': 'OS', 'timeFrame': '5 years', 'description': 'overall survival'}, {'measure': 'Surrogate marker: Interleukin 6 (IL-6)', 'timeFrame': '5 years', 'description': 'surrogates of tumor and inflammation from routine blood draws \\[ng/l\\]'}, {'measure': 'Surrogate marker: Carcinoembryonic Antigen (CEA)', 'timeFrame': '5 years', 'description': 'surrogates of tumor and inflammation from routine blood draws, \\[mg/l\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total neoadjuvant therapy (TNT)', 'T2* MRI', 'circulating tumor cells', 'tumor infiltrating lymphocytes', 'liquid biopsy', 'DWI', 'rectal cancer', 'organ preservation'], 'conditions': ['Locally Advanced Rectal Carcinoma', 'Neoadjuvant Treatment', 'Radiotherapy', 'Adaptive Treatment']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.', 'detailedDescription': 'Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after CRT. Resection is standard after completion of preoperative treatment. In case of complete regression and patient\'s request, a non-operative management ("watch and wait") is offered alternatively. The primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and TILs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced rectal cancer (LARC), receiving neoadjuvant chemoradiotherapy (CRT).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* locally advanced rectal cancer (LARC): UICC Stage II/III\n* no severe cardiac or lung disease\n* no severe hepatic disorders (liver enzymes \\<2.5 NR) or restrictions of renal function (GFR \\> 30ml/min)\n* no severe cytopenia (Neutrocytes \\>= 3 Gpt/l; Thrombocytes \\>= 100 Gpt/l; Hemoglobin \\>6mmol/l)\n* no homozygotic DPD deficiency\n* no other neoplasms requiring therapy\n* no earlier radiotherapy of the pelvis or earlier chemotherapy\n* no contraindications for MRI'}, 'identificationModule': {'nctId': 'NCT05524012', 'acronym': 'PRIMO', 'briefTitle': 'Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Planning Adaptive Treatment by Longitudinal Response Assessment Implementing MR Imaging, Liquid Biopsy and Analysis of Microenvironment During Neoadjuvant Treatment of Rectal Cancer (PRIMO)', 'orgStudyIdInfo': {'id': 'UKJ-PRIMO-2022'}, 'secondaryIdInfos': [{'id': 'CSP-11', 'type': 'OTHER_GRANT', 'domain': 'Clinician Scientist Program, Interdisciplinary Center for Clinical Research, Jena University Hospital'}, {'id': 'LIFE Talent Funds 2022', 'type': 'OTHER_GRANT', 'domain': 'Friedrich Schiller University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['analyses of circulating tumor cells (CTC)'], 'description': 'longitudinal blood samples for CTC monitoring'}, {'name': 'MRI scan', 'type': 'DEVICE', 'otherNames': ['multiparametric (incl. DWI and T2* "BOLD")'], 'description': 'longitudinal MRI scans (non-contrast enhanced)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jena', 'country': 'Germany', 'facility': 'Department of Radiotherapy and Radiation Oncology, Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Andrea Wittig-Sauerwein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department for Radiotherapy and Radiooncology, Jena University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Georg Wurschi', 'investigatorAffiliation': 'Jena University Hospital'}}}}