Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-03-26 @ 1:25 AM
Study NCT ID:
NCT05457595
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar 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'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}], 'ancestors': [{'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', 'interventionModelDescription': 'Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local control', 'timeFrame': '1 year after treatment', 'description': 'absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies'}, {'measure': 'complete response', 'timeFrame': '1 year after treatment', 'description': 'complete regression of the tumor lesion'}, {'measure': 'partial response', 'timeFrame': '1 year after treatment', 'description': 'Reduction of the tumor volume \\> 65% of the initial volume'}, {'measure': 'stable disease', 'timeFrame': '1 year after treatment', 'description': 'Volume between PR and PD'}, {'measure': 'progression disease', 'timeFrame': '1 year after treatment', 'description': 'Volume increase \\> 73% of the initial volume.'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 year after treatment', 'description': 'overall survival'}, {'measure': 'Toxicity assessment according to CTCAE v. 5', 'timeFrame': '1 year after treatment', 'description': 'Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)'}, {'measure': 'Progression free survival', 'timeFrame': '1 year after treatment', 'description': 'Progression free survival (PFS) with qualitative evaluation as a narrative of progression'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gynecological cancer', 'carbon ion radiation therapy', 'recurrencies', 'CIRT'], 'conditions': ['Tumor Recurrence', 'Malignant Epithelial Neoplasm of Vulva', 'Malignant Epithelial Tumor of Ovary', 'Malignant Epithelial Neoplasm']}, 'descriptionModule': {'briefSummary': 'The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).', 'detailedDescription': 'Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies.\n\nSecondary aims:\n\n1. To describe the safety profile of carbon ion therapy.\n2. To estimate the effect, in terms of survival, of carbon ion treatment'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The research applies to gynecological tumors.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Karnofsky Index ≥ 70\n* Histological or radiological diagnosis of pelvic and groin recurrence\n* Contraindications for radical surgery\n* No other distant progression or stable disease (SD) of known secondarisms (≥6 months)\n* Previous radiation therapy on pelvis\n* Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated\n* Possibility to perform a surgery to space the intestinal loops, in case of distance \\< 10mm\n* If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.\n* DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability\n* Written informed consent\n* Patient's ability to understand the characteristics and consequences of the clinical trial\n\nExclusion Criteria:\n\n* Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan\n\n * Intestinal infiltration\n * Bladder infiltration\n * Vessel infiltration\n * Previous therapy with anti-angiogenesis drugs\n * Psychic or other disorders that may prevent informed consent\n * Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years\n * Spacer in absorbable material (i.e. vycril)\n * Distance \\< 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated\n * Impossibility to assess MRI"}, 'identificationModule': {'nctId': 'NCT05457595', 'acronym': 'CYCLOPS', 'briefTitle': 'Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'CNAO National Center of Oncological Hadrontherapy'}, 'officialTitle': 'Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies', 'orgStudyIdInfo': {'id': 'CNAO 41 2020C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carbon ion radiotherapy', 'description': 'All enrolled subjects will undergo carbon ion radiation therapy. Patients affected by pelvic recurrence of gynecological neoplasia, already undergone to radiotherapy on pelvis, will be enrolled in the study.', 'interventionNames': ['Radiation: carbon ion radiation therapy']}], 'interventions': [{'name': 'carbon ion radiation therapy', 'type': 'RADIATION', 'otherNames': ['CIRT'], 'description': 'CIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks.\n\nTreatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted.', 'armGroupLabels': ['carbon ion radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Pv', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Bono, MSc', 'role': 'CONTACT', 'email': 'cristina.bono@cnao.it', 'phone': '0382078613'}], 'facility': 'CNAO', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Amelia Barcellini, MD', 'role': 'CONTACT', 'email': 'amelia.barcellini@cnao.it', 'phone': '390382075501'}, {'name': 'Cristina Bono, MSc', 'role': 'CONTACT', 'email': 'cristina.bono@cnao.it', 'phone': '390382075613'}], 'overallOfficials': [{'name': 'Amelia Barcellini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CNAO National Center of Oncological Hadrontherapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CNAO National Center of Oncological Hadrontherapy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}