Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-17 @ 7:58 AM
Study NCT ID:
NCT02072720
Status:
UNKNOWN
Last Update Posted:
2019-10-02
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angiogenic Factor Expression During Fractionated Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of VEGF mRNA expression in tumor biopsies', 'timeFrame': '5 weeks', 'description': 'To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline.'}, {'measure': 'Change of VEGFR2 phosphorylation with IHC', 'timeFrame': '8 weeks', 'description': 'To determine the level of pVEGFR2 expression in tumor biopsies of patients that received bevacizumab, and to compare that to their pre-treatment expression levels, to identify the changes in expression from baseline.'}], 'secondaryOutcomes': [{'measure': 'Changes of mRNA expression of other pro-angiogenic factors', 'timeFrame': '5 weeks', 'description': 'To identify the expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).'}, {'measure': 'Changes in protein expression of pro-angiogenic factors', 'timeFrame': '5 weeks', 'description': 'To identify the protein expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).'}, {'measure': 'Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis', 'timeFrame': '5 weeks', 'description': 'To identify the expression of CD31+ and pericyte markers with IHC staining in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Radiotherapy', 'VEGF', 'esophagus carcinoma', 'bevacizumab'], 'conditions': ['Primary Esophageal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.\n\n* Therefore the first aim of this study is to identify the time point of induction of VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation).\n* If we identify increased expression of VEGF at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma\n* ability to give informed consent\n* age 18 years or older\n\nExclusion Criteria:\n\n* pregnancy\n* evidence of bleeding diathesis, coagulopathy\n* inflammation of the GI-tract\n* brain metastases\n* diastolic/ systolic hypertension, not responding to treatment\n* arterial thromboembolism in medical history\n* surgery within the month prior to start of bevacizumab treatment'}, 'identificationModule': {'nctId': 'NCT02072720', 'briefTitle': 'Angiogenic Factor Expression During Fractionated Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma', 'orgStudyIdInfo': {'id': '2013/340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'on-treatment tumor biopsie', 'description': 'patients will undergo an pre-treatment and on-treatment tumor biopsy, to measure VEGF expression, and identify the time point of induction of VEGF expression.'}, {'type': 'EXPERIMENTAL', 'label': 'bevacizumab', 'description': 'These patients will receive bevacizumab once a week during their chemoradiation, starting at the identified time point of enhanced VEGF expression. These patients will also undergo and pre-treatment tumor biopsy and 1 tumor biopsy 1 week after the start of bevacizumab treatment.', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Bevacizumab (Avastin).'], 'description': 'patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression', 'armGroupLabels': ['bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081 HV', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Henk Verheul, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VU university medical center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Alkmaar', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'A. M. Van Berkel', 'role': 'CONTACT'}], 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'H. W.M. van Laarhoven', 'role': 'CONTACT'}], 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Henk Verheul, MD/ PhD', 'role': 'CONTACT', 'email': 'h.verheul@vumc.nl'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Noordwest Ziekenhuisgroep', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. H.M.W. Verheul', 'investigatorFullName': 'H.M.W. Verheul', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}