Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-28 @ 2:29 AM
Study NCT ID:
NCT01191632
Status:
UNKNOWN
Last Update Posted:
2010-10-22
First Post:
2010-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2010-08-20', 'studyFirstSubmitQcDate': '2010-08-30', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumor activity', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To determine local control and recurrence patterns of colorectal liver metastases in a CT', 'timeFrame': '2 years'}, {'measure': 'To determine the progression-free survival in patients treated with low dose photon beam radiation therapy', 'timeFrame': '2 years'}, {'measure': '• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment', 'timeFrame': '2 years'}, {'measure': '• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment', 'timeFrame': '2 years'}, {'measure': '• To determine the T-cell activity in the resected liver tissue', 'timeFrame': '2 years'}, {'measure': '• To determine quality of life according to the EORTC QoL questionnaire after 6 months.', 'timeFrame': '6 months'}, {'measure': 'To determine the number of regulatory T-cells in the resected liver tissue', 'timeFrame': '2 years'}, {'measure': 'To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients', 'timeFrame': '2 years'}, {'measure': 'To determine quality of life according to the EORTC QoL questionnaire after 12 months.', 'timeFrame': '1 year'}, {'measure': 'To determine the number of patients with adverse events as a measure of safety and tolerability according to CTCAE, Version 4.0 criteria', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['T cell', 'surgery', 'radiation'], 'conditions': ['Colorectal Liver Metastases']}, 'referencesModule': {'references': [{'pmid': '21961577', 'type': 'DERIVED', 'citation': 'Reissfelder C, Timke C, Schmitz-Winnenthal H, Rahbari NN, Koch M, Klug F, Roeder F, Edler L, Debus J, Buchler MW, Beckhove P, Huber PE, Weitz J. A randomized controlled trial to investigate the influence of low dose radiotherapy on immune stimulatory effects in liver metastases of colorectal cancer. BMC Cancer. 2011 Sep 30;11:419. doi: 10.1186/1471-2407-11-419.'}]}, 'descriptionModule': {'briefSummary': 'The efficiency of T cell based immunotherapies is affected by the insufficient migration and activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell connected anti tumor immune response in colorectal liver metastases.\n\nThe primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell activity in situ, the number of regulatory T cells and the frequency of tumor reactive T cells in the blood and bone marrow will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent (must be available before enrolment in the trial)\n* Age ≥ 50 years\n* Radiological urgently suspected colorectal liver metastasis\n\nExclusion Criteria:\n\n* second malignancy\n* Pregnancy and lactation\n* no prior liver radiation\n* liver metastasis must be resectable'}, 'identificationModule': {'nctId': 'NCT01191632', 'briefTitle': 'Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Randomised Controlled Phase I/II Trail to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation Therapy in Resectable Colorectal Liver Metastases Patients', 'orgStudyIdInfo': {'id': 'S081/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiation 0,5Gy', 'description': 'Radiation: one time Radiation with an intensity of 0.5 Gy Group A\n\nBeginning on a weekday 48 hours before surgery', 'interventionNames': ['Radiation: one time radiation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No radiation', 'description': 'Control group with 0Gy radiation', 'interventionNames': ['Radiation: No Radiation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiation 2Gy', 'description': 'Radiation: one time Radiation with an intensity of\n\n2.0 Gy Group B\n\nBeginning on a weekday 48 hours before surgery', 'interventionNames': ['Radiation: one time radiation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiation 5Gy', 'description': 'Radiation: one time Radiation with an intensity of\n\n5 Gy Group C Beginning on a weekday 48 hours before surgery', 'interventionNames': ['Radiation: one time radiation']}], 'interventions': [{'name': 'one time radiation', 'type': 'RADIATION', 'description': 'Radiation: one time Radiation with an intensity of\n\n0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery', 'armGroupLabels': ['Radiation 0,5Gy', 'Radiation 2Gy', 'Radiation 5Gy']}, {'name': 'No Radiation', 'type': 'RADIATION', 'description': 'Control group with 0Gy', 'armGroupLabels': ['No radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Juergen Weitz', 'role': 'CONTACT', 'email': 'juergen.weitz@med.uni-heidelberg.de', 'phone': '+49 6221 56 6250'}, {'name': 'Christoph Reissfelder', 'role': 'CONTACT', 'email': 'christoph.reissfelder@med.uni-heidelberg.de', 'phone': '+49 6221 56 6250'}], 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Juergen Weitz, MD', 'role': 'CONTACT', 'email': 'juergen.weitz@med.uni-heidelberg.de', 'phone': '+49 6221 56 6250'}, {'name': 'Christoph Reissfelder, MD', 'role': 'CONTACT', 'email': 'christoph.reissfelder@med.uni-heidelberg.de', 'phone': '+49 6221 56 6250'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Juergen Weitz', 'oldOrganization': 'Department of surgery, university of Heidelberg'}}}}