Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-29 @ 5:53 PM
Study NCT ID:
NCT05172635
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2021-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-12', 'studyFirstSubmitDate': '2021-11-28', 'studyFirstSubmitQcDate': '2021-12-12', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological response of the primary tumour', 'timeFrame': 'Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery.', 'description': 'Investigation of the tumour response of the primary tumor (colorectal carcinoma) using the Rödel Score (tumour regression score)'}], 'secondaryOutcomes': [{'measure': 'Pathological response of the liver metastases', 'timeFrame': 'Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery. Radiological response was assessed in staging CT abdomen 2 to 4 weeks after induction chemotherapy.', 'description': 'Investigation of the tumour response of the liver metastases using Rubbia Brand score (Tumour regression score) and using radiological assessment'}, {'measure': 'Overall survival', 'timeFrame': 'median of 21 months (0 to 80)', 'description': 'Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment'}, {'measure': 'Recurrece free survival', 'timeFrame': 'median of 21 months (0-80)', 'description': 'Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment'}, {'measure': '90 day mortality', 'timeFrame': '90 days', 'description': 'number of patients, who died less than 90 days after liver surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'synchronous liver metastases', 'targeted therapy', 'tumour regression grading'], 'conditions': ['Gastrointestinal Neoplasm']}, 'descriptionModule': {'briefSummary': 'We performed a retrospective data analysis of patients with synchronously metastasized colorectal cancer, comparing the histological response on the primary tumour to chemotherapy combined with either vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR) inhibition.', 'detailedDescription': 'We performed a retrospective analysis regarding the response of the primary tumour and the liver metastases of patients with colorectal carcinoma to an induction chemotherapy with antibody therapy, either with a VEGF antibody, or with an EGFR antibody.\n\nWe investigated 100 Patients with synchronous metastatic colorectal carcinoma, who underwent hepatic resection in Clinic Landstraße or Clinic Favoriten between 2014 and 2021.\n\nWe investigated the tumour response of the primary tumour, using Rödel score, which is a tumour regression score.\n\nWe also investigated the tumour response of the liver metastases using Rubbia Brandt tumour regression score.\n\nThe pathological response was assessed postoperatively in the surgical specimen. In order to ensure a uniform assessment, the pathologists in our HPB center assessed the histological specimens from both treatment locations prior to this analyses.\n\nThe tumour response of the liver metastases was assessed twice: by radiological tumour assessment via computer tomography (CT) of the abdomen or magnetic resonance imaging (MRI) of the liver with RECIST criteria.\n\nPostoperative complications less than 90 days after liver resection were assessed and described according to the classification system by Dindo et al.\n\nDay of tumour recurrence and/or death was assessed.\n\nWe also investigated the difference of recurrence free Survival (RFS) and Overall surcical (OS) between the patients, who received EGFR and the patients, who received VEGF antibody treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients had synchronously metastasized colorectal cancer and received surgical treatment because of their liver metastases in either Clinic Landstrasse or Clinic Favoriten (HPB center) in Vienna from June 2014 to February 2021..', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years\n* synchronously hepatic metastasized patients with colorectal carcinoma\n* indication of surgical treatment\n\nExclusion Criteria:\n\n* younger than 18 years\n* metachronously metastasized patients'}, 'identificationModule': {'nctId': 'NCT05172635', 'briefTitle': 'Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Klinik Favoriten'}, 'officialTitle': 'Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients, who received a VEGF antibody', 'description': 'We distinguished between patients who received a VEGF antibody therapy and patients who received a EGFR antibody therapy.'}, {'label': 'Patients, who received a EGFR antibody', 'description': 'We distinguished between patients who received a VEGF antibody therapy and patients who received a EGFR antibody therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Vienna', 'state': 'Vienna/Austria', 'country': 'Austria', 'facility': 'Clinic Favoriten', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Thomas Gruenberger, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic Favoriten (HPB center)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik Favoriten', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prim. Prof. Dr. med.', 'investigatorFullName': 'Thomas Gruenberger', 'investigatorAffiliation': 'Klinik Favoriten'}}}}