Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-05 @ 10:48 AM
Study NCT ID:
NCT02017366
Status:
WITHDRAWN
Last Update Posted:
2023-12-06
First Post:
2013-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design of the EFECTS Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}], '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'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'adapted protocol with changed outcome measures, changed recruitment number, no submission to ethical board review', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival from day of surgery', 'timeFrame': '5 years postoperative', 'description': 'overall survival at 5 years after esophagectomy'}], 'secondaryOutcomes': [{'measure': 'postoperative weight loss', 'timeFrame': '1 year after surgery', 'description': 'weight loss will be calculated by using age- and gender corrected BMI percentiles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgery', 'Malnutrition', 'Nutrition, Enteral'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.\n\nWe believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.\n\nWe hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced cT2 N+ or cT3 Nx\n* all histology\n* GEJ or distal esophageal ACC\n* proximal or mid SCC\n* curative intent with intention to treat\n* no M+\n* at least two-field lymphadenectomy\n* all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis\n* all anastomosis (intrathoracic, cervical)\n\nExclusion Criteria:\n\n* T4\n* R2\n* transhiatal\n* pt in definitive CRT or rescue resection following definitive CRT\n* palliative treatment\n* tumours in cervical esophagus\n* pharyngeal cancer with gastric pull-up'}, 'identificationModule': {'nctId': 'NCT02017366', 'acronym': 'EFECTS', 'briefTitle': 'Design of the EFECTS Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'officialTitle': 'Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival', 'orgStudyIdInfo': {'id': 'EFECTS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group = standard of Care regimen: 1000ml = 1000 kCal TPN postop from day 1 until day 7. Oral feeds are started from day 5 onwards if no arguments for clinical leak (cervical anastomosis) or barium swallow is normal. Oral intake consists of regular post gastrectomy diet (building up from fluids over semi-solids to solids) with eventually added high nitrogen energy drinks.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enteral feeding', 'description': 'Treatment group: start jejunostomy feeds from day 1, with target of 1000ml = 1000kCal (= 40cc/hour). To equilibrate energy intake during build up fase, Glucose 20% is given at a total cumulative dose taking into account the dose of j-drip, cumulative not exceeding 40cc/hr. Oral feeds are started at the same time as in the control group (reg. day 5) Jejunostomy feeds are then continued for 6 weeks together with oral intake with a continuous energy administration of 1000kCal, and then stopped. After this time, patients should be on regular full diet in both groups. If failure and step-back needed, temporary switch to Glc 20% is done to maintain fluid and calory administration.', 'interventionNames': ['Other: Enteral feeding']}], 'interventions': [{'name': 'Enteral feeding', 'type': 'OTHER', 'description': 'Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.', 'armGroupLabels': ['Enteral feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vl-Brabant', 'country': 'Belgium', 'facility': 'University hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Hans Van Veer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Philippe Nafteux, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Willy Coosemans, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Johnny Moons, MScN', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Paul De Leyn, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hans Van Veer, MD', 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}