Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01344304
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2011-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'C579707', 'term': 'fosaprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient diary recording nausea, emesis, food ingestion, and rescue therapy', 'timeFrame': 'From initiating administration of anticancer agents to day 6 (120 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aprepitant therapy', 'fosaprepitant therapy', '5HT3-receptor antagonist', 'dexamethasone', 'colorectal cancer', 'FOLFOX', 'XELOX', 'SOX'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥20 years old\n* Sex: Not specified\n* Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).\n* Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)\n* Combination of molecular targeted therapy: allowable\n* Written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Severe liver or kidney disease\n* Nausea/vomiting within 24 hr prior to chemotherapy.\n* Treatment with antiemetics within 24 hr prior to chemotherapy.\n* Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)\n* Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)\n* Pregnant or lactating women, women who plan to become pregnant.\n* Current treatment with pimozide.\n* Any patient judged to be inappropriate for the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT01344304', 'briefTitle': 'Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial', 'organization': {'class': 'OTHER', 'fullName': 'Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group'}, 'officialTitle': 'Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy', 'orgStudyIdInfo': {'id': 'SENRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard therapy', 'description': 'The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone'}, {'type': 'EXPERIMENTAL', 'label': 'Aprepitant / Fosaprepitant therapy', 'description': 'The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.', 'interventionNames': ['Drug: Aprepitant / Fosaprepitant']}], 'interventions': [{'name': 'Aprepitant / Fosaprepitant', 'type': 'DRUG', 'description': 'Aprepitant:\n\n125 mg PO on day 1 80 mg PO on days 2 to 3\n\nFosaprepitant:\n\n150 mg IV on day 1', 'armGroupLabels': ['Aprepitant / Fosaprepitant therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6600064', 'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kansai Rosai Hospital', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'zip': '6640872', 'city': 'Itami', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kinki Central Hospital', 'geoPoint': {'lat': 34.78427, 'lon': 135.40126}}, {'zip': '6520042', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kawasaki Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '6300293', 'city': 'Ikoma', 'state': 'Nara', 'country': 'Japan', 'facility': 'Nara Hospital Kinki University Faculty of Medicine', 'geoPoint': {'lat': 34.68333, 'lon': 135.7}}, {'zip': '5788588', 'city': 'Higashiosaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Higashiosaka City General Hospital', 'geoPoint': {'lat': 34.66667, 'lon': 135.58333}}, {'zip': '5670085', 'city': 'Ibaraki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Saito Yukoukai Hospital', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '5988577', 'city': 'Izumisano', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Rinku General Medical Center', 'geoPoint': {'lat': 34.41667, 'lon': 135.31667}}, {'zip': '5970015', 'city': 'Kaizuka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kaizuka City Hospital', 'geoPoint': {'lat': 34.45, 'lon': 135.35}}, {'zip': '5800023', 'city': 'Matsubara', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Hannan Chuo Hospital', 'geoPoint': {'lat': 34.56667, 'lon': 135.55}}, {'zip': '5620014', 'city': 'Minoo', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Minoh City Hospital'}, {'zip': '5900064', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Sakai City Hospital', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '5918025', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Rosai Hospital', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '5640082', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Suita Municipal Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '5650862', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Saiseikai Senri Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Graduate School of Medicine / Faculty of Medicine, Osaka University', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '5608565', 'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Toyonaka Municipal Hospital', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'zip': '5810069', 'city': 'Yao', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Yao Municipal Hospital', 'geoPoint': {'lat': 34.61667, 'lon': 135.6}}, {'zip': '5300001', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Kenporen Osaka Central Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5330022', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Iseikai Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5378511', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical Center for Cancer and Cardiovascular Diseases', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5400006', 'city': 'Osaka', 'country': 'Japan', 'facility': 'National Hospital Organization Osaka National Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5430042', 'city': 'Osaka', 'country': 'Japan', 'facility': 'NTT West Osaka Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5500012', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Nissay Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5500024', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Tane General Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5520021', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Seninhoken Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5530003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Koseinenkin Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5588558', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka General Medical Center', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}