Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-04 @ 2:41 PM
Study NCT ID:
NCT06314568
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer
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': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Control', 'timeFrame': '6 months', 'description': 'Local control, the Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment'}], 'secondaryOutcomes': [{'measure': 'Cancer specific overall survival', 'timeFrame': '6 months', 'description': 'The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment'}, {'measure': 'Toxicities', 'timeFrame': '6 months', 'description': 'The safety and tolerability profile of the treatment will be defined by the frequency and severity of adverse reactions as well as their possible correlation with the treatment received.'}, {'measure': 'Overall survivall', 'timeFrame': '6 months', 'description': 'The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment'}, {'measure': 'Disease free survivall', 'timeFrame': '6 months', 'description': 'The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment'}, {'measure': 'Metastasis free survival', 'timeFrame': '6 months', 'description': 'The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment'}, {'measure': 'Changes in quality of life over time', 'timeFrame': '6 months', 'description': 'Anova for repeated measures or the corresponding non-parametric Friedman test will be used to identify changes in quality of life over time.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Cancer']}, 'descriptionModule': {'briefSummary': 'Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer', 'detailedDescription': 'Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age more than18 years old\n* Performance status 0,1\n* Hystological diagnosis of squamous vaginal cancer\n* HPV, p16, p53 status\n* Stage I, II, III and IV (AJCC 2018th version)\n* Stadiation with magnetic resonance and positron emission tomography\n* Informed consensus\n\nExclusion Criteria:\n\n* Age inferior 18 years old\n* Performance status more than 2\n* Previous cancer in the last ten years\n* Previous radiation treatment in the region of interest\n* Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)\n* Presence of internal pathologies that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)\n* Presence of distant metastases in sites other than the pelvic lymph nodes\n* Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study"}, 'identificationModule': {'nctId': 'NCT06314568', 'acronym': 'TRIDENT', 'briefTitle': 'Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Radiochemotherapy Treatment Followed by Interventional Radiotherapy in Patients Affected by Vagina Carcinoma Multi-centric Prospective Observational Study Trimodal Definitive Invasive Vaginal Carcinoma Treatment', 'orgStudyIdInfo': {'id': '6350'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with vaginal cancer', 'description': 'Patients affected by vaginal cancer', 'interventionNames': ['Radiation: Radiochemotherapy plus interventional radiotherapy']}], 'interventions': [{'name': 'Radiochemotherapy plus interventional radiotherapy', 'type': 'RADIATION', 'description': 'All patients with vaginal cancer will undergo radiochemotherapy (45 Gy on pelvis and tumor in association with cisplatinum) plus interventional radiotherapy (28 Gy on residual disease) with exclusive intent', 'armGroupLabels': ['Patients with vaginal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'VALENTINA LANCELLOTTA', 'role': 'CONTACT', 'email': 'valentina.lancellotta@policlinicogemelli.it', 'phone': '+390630155701'}, {'name': 'VALENTINA LANCELLOTTA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'VALENTINA LANCELLOTTA, MD', 'role': 'CONTACT', 'email': 'valentina.lancellotta@policlinicogemelli.it', 'phone': '+390630155701'}], 'overallOfficials': [{'name': 'VALENTINA LANCELLOTTA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}