Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-06 @ 9:01 PM
Study NCT ID:
NCT06514235
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014625', 'term': 'Vaginal Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014623', 'term': 'Vaginal 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': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-28', 'size': 2906428, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-14T09:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2033-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local failure', 'timeFrame': '2 and 5 years of follow-up', 'description': 'A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).'}, {'measure': 'Late physician-assessed morbidity and patient reported outcomes', 'timeFrame': '2 and 5 years of follow-up', 'description': 'Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).'}, {'measure': 'Acute physician-assessed morbidity and patient reported outcomes', 'timeFrame': 'End of Treatment', 'description': 'Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).'}], 'secondaryOutcomes': [{'measure': 'Other oncological outcomes', 'timeFrame': '2 and 5 years of follow-up', 'description': 'Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to improve clinical outcomes of patients with vaginal cancer including vaginal recurrences who are treated with curative intent by primary radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT).\n\nBeing an observational, prospective registration study, wherein neither an experimental treatment is compared to the standard treatment, nor groups of patients are compared.\n\nThe specific aims are:\n\n* to develop evidence-based recommendations for curative intent treatment with primary radio(chemo)therapy and IGABT.\n* to identify prognostic parameters for oncological outcomes, morbidity and quality of life.\n\nThe study aims to enroll at least 300 patients. Oncological events will be evaluated at 2 and 5 years of follow-up. Acute and late morbidity events will be evaluated at end of treatment, 2 and 5 years of follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with primary vaginal cancer stage I-IVA or vaginal recurrence from any gynaecologial cancer who are treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\no Histologically proven primary vaginal cancer, vaginal carcinoma in situ (VAIN) or vaginal recurrence, per WHO classification.\n\nHistological proven stage I-IVA primary vaginal cancer: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the vagina, other epithelial carcinoma's and carcinoma in situ\n\n* Histological proven vaginal recurrence from any gynaecological cancer for whom curative treatment is envisioned that includes image guided adaptive brachytherapy according to the target concept.\n* Para-aortic lymph node metastasis below L1-L2 interspace are allowed\n* Macroscopic visible tumour present on MRI and/or gynaecological examination at diagnosis.\n* Planned IGABT treatment with MRI-guided adaptive brachytherapy (at least the 1st fraction contouring and planning on MRI; CT for later fractions is allowed):\n\n * External beam radio(chemo)therapy followed by IGABT\n * IGABT alone for stage I \\<2cm or carcinoma in situ\n* Treatment with curative intent\n* Written informed consent\n\nExclusion Criteria:\n\n* Primary vaginal cancers with involvement of the ostium of the cervix or vulva (these should be classified as cervical cancer or vulvar cancer, respectively)\n* Metastatic disease beyond para-aortic region L1-L2 interspace\n* Sarcomas and melanomas.\n* Treatment only by external beam radiotherapy without brachytherapy to boost the primary disease\n* Primary vaginal cancer: treatment by primary surgery or debulking surgery\n* Vaginal recurrences: treatment by primary surgery or debulking surgery\n* Treatment with neo-adjuvant chemotherapy followed by surgery\n* Treatment with radiotherapy followed by surgery\n* Previous pelvic or abdominal radiotherapy\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT06514235', 'acronym': 'EMBRAVE', 'briefTitle': 'Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr', 'orgStudyIdInfo': {'id': 'MEC-2021-0820'}, 'secondaryIdInfos': [{'id': 'PaNaMa ID 6517', 'type': 'OTHER', 'domain': 'ErasmusMC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer', 'description': 'Adult patients with vaginal cancer treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy according to the protocol target concept.', 'interventionNames': ['Other: Observational study (Non-interventional study)']}], 'interventions': [{'name': 'Observational study (Non-interventional study)', 'type': 'OTHER', 'description': 'This is an observational study.', 'armGroupLabels': ['Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 CD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Remi A. Nout, PhD', 'role': 'CONTACT', 'email': 'r.nout@erasmusmc.nl', 'phone': '+31107041366'}, {'name': 'René M. Vernhout, MSc', 'role': 'CONTACT', 'email': 'r.vernhout@erasmusmc.nl', 'phone': '+31107041341'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Remi A. Nout, PhD', 'role': 'CONTACT', 'email': 'r.nout@erasmusmc.nl', 'phone': '+31107041366'}, {'name': 'René M. Vernhout, MSc', 'role': 'CONTACT', 'email': 'r.vernhout@erasmusmc.nl', 'phone': '+31107041341'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Amsterdam University Medical Center', 'class': 'OTHER'}, {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, {'name': 'Pitié-Salpêtrière Hospital', 'class': 'OTHER'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Prof. Dr. Remi A. Nout', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}