Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-05 @ 1:09 AM
Study NCT ID:
NCT04386993
Status:
COMPLETED
Last Update Posted:
2025-10-20
First Post:
2020-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events', 'timeFrame': 'From start of radiation through Day 90'}, {'measure': 'Incidence of late hematologic, gastrointestinal, and genitourinary adverse events', 'timeFrame': 'From Day 91 through month 12'}], 'secondaryOutcomes': [{'measure': 'Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE', 'timeFrame': 'Baseline, 2 weeks, and 3 months post-completion of radiation', 'description': '* PRO-CTCAE responses are scored from 0 to 4 with 0=Never/Not at all/None and 4=Frequently/Very Much/Very Severe/Almost Constantly\n* Scores for each attribute (frequency, severity and/or interference) will be presented descriptively'}, {'measure': 'Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26', 'timeFrame': 'Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation', 'description': '* Bladder has 7 questions and bowel has 9 questions\n* The response for each item is standardized to a 0 to 100 scale\n* The standardized values will be averaged for all items within a group to create the summary or subscale score.'}, {'measure': 'Change in quality of life as measured by FACT-En', 'timeFrame': 'Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation', 'description': '* Questionnaire asking questions about physical well-being, social/family well-being, emotional well-being, functional well-being, and other additional concerns. Answers range from 0 = not at all to 4 = very much. Questions are phrased so that higher numbers indicate a better health state,\n* Scoring is performed through a simple sum of item scores. Each subscale is scored, and a total score is obtained by adding each of the subscale scores.'}, {'measure': 'Locoregional control', 'timeFrame': 'Up to 12 months post-completion of radiation', 'description': '-Locoregional recurrence is defined as histologic or radiographic evidence of cancer in the previously resected site or regional lymph nodes included in the radiated field.'}, {'measure': 'Distant control', 'timeFrame': 'Up to 12 months post-completion of radiation', 'description': '-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.'}, {'measure': 'Disease-free survival', 'timeFrame': 'Up to 12 months post-completion of radiation', 'description': '-Disease-free survival is defined as survival with no evidence of disease recurrence or death'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 12 months post-completion of radiation', 'description': '-Number of participants alive at the time of completion of follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Endometrial Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate \\< 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology.\n* Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Minimal bone marrow and organ function as defined below:\n\n * Leukocytes ≥ 1,000 cumm\n * Absolute neutrophil count ≥ 500 cumm\n * Platelets ≥ 50,000 cumm\n * Hemoglobin ≥ 7g/dL\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior radiation to the pelvis.\n* Currently receiving any investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.'}, 'identificationModule': {'nctId': 'NCT04386993', 'acronym': 'DeCRESCEndo', 'briefTitle': 'De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)', 'orgStudyIdInfo': {'id': '202004237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMRT', 'description': '-Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy.\n\n-\\*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks', 'interventionNames': ['Radiation: Intensity modulated radiation therapy']}], 'interventions': [{'name': 'Intensity modulated radiation therapy', 'type': 'RADIATION', 'otherNames': ['IMRT'], 'description': 'Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).', 'armGroupLabels': ['IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Jessika Contreras, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Proposals may be submitted up to 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) for individual participant data meta-analysis by investigators whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose.', 'accessCriteria': 'Please contact Dr. Jessika Contreras.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}