Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-06 @ 5:17 AM
Study NCT ID:
NCT02957266
Status:
UNKNOWN
Last Update Posted:
2016-11-15
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical 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': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D019908', 'term': 'Proto-Oncogene Proteins c-raf'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D048490', 'term': 'raf Kinases'}, {'id': 'D020930', 'term': 'MAP Kinase Kinase Kinases'}, {'id': 'D017346', 'term': 'Protein Serine-Threonine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011518', 'term': 'Proto-Oncogene Proteins'}, {'id': 'D015513', 'term': 'Oncogene Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Progressive Disease', 'timeFrame': '4 years'}, {'measure': 'Incidence of acute toxicity', 'timeFrame': 'Up to 30 days after completion of radiation therapy'}, {'measure': 'Incidence of late toxicity', 'timeFrame': 'Up to 2 years after completion of radiation therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'interstitial brachytherapy', 'gemcitabine', 'volumetric arc therapy'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define an effectiveness of concurrent chemoradiotherapy of cervical cancer patients treated by VMAT (volumetric arc therapy) based external beam radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial brachytherapy.', 'detailedDescription': 'Now cisplatin based concurrent chemoradiotherapy for cervical cancer is a standard treatment modality. But we consider that the treatment results could be improved by several ways: 1. use of VMAT (volumetric arc therapy) based external beam radiotherapy could decrease toxicity by reducing of unnecessarily irradiated tissue volumes; 2. in addition to cisplatin gemcitabine could enhance tumor cell damaging effect of radiation; 3. interstitial brachytherapy could provide higher radiation dose boost to high risk tumor volume while sparing surrounding organs at risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically confirmed primary invasive carcinoma of the uterine cervix Previously untreated disease Any cell type Stage IB2, IIA, IIB, IIIA, IIIB, or IVA Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy No known metastases to scalene nodes or other organs outside the radiotherapy field Study enrollment within 8 weeks of diagnosis Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm\\^3 Platelet count at least 100,000/mm\\^3 Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Creatinine less than 2.0 mg/dL No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields No bilateral ureteral obstruction allowed unless treated with stent or nephrostomy tube Not pregnant Fertile patients must use effective contraception No septicemia or severe infection No circumstance that would preclude study completion or follow-up No other malignancy within the past 5 years except nonmelanoma skin cancer No prior cytotoxic chemotherapy No prior pelvic or abdominal radiotherapy No prior therapy for this malignancy\n\nExclusion Criteria:\n\nPregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events.(Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.\n\nGrowth factor(s): Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days.\n\nErythropoietic drug(s): Erythropoietin or related hormones must not have been administered within the past 28 days.\n\nInfection: Patients who have an uncontrolled infection. Evidence of distant metastases Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years.\n\nPrior systemic chemotherapy within the last three years. Prior radiotherapy to the pelvis'}, 'identificationModule': {'nctId': 'NCT02957266', 'acronym': 'CERVIPIB', 'briefTitle': 'Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The National Center of Oncology, Azerbaijan'}, 'officialTitle': 'Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy', 'orgStudyIdInfo': {'id': 'MOM-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classical treatment', 'description': 'Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates.', 'interventionNames': ['Radiation: Volumetric Arc Radiotherapy', 'Drug: Cisplatin', 'Genetic: PIK3CA', 'Genetic: KRAS', 'Genetic: BRAF', 'Genetic: RRM1']}, {'type': 'EXPERIMENTAL', 'label': 'GemInterBraVMAT', 'description': 'Concurrent chemoradiotherapy of cervical cancer patients treated by VMAT (volumetric arc radiotherapy) based external beam radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial brachytherapy.\n\nPIK3CA, KRAS, BRAF and RRM1 mutations rates.', 'interventionNames': ['Radiation: Volumetric Arc Radiotherapy', 'Radiation: Interstitial brachytherapy', 'Drug: Cisplatin', 'Drug: Gemcitabine', 'Genetic: PIK3CA', 'Genetic: KRAS', 'Genetic: BRAF', 'Genetic: RRM1']}], 'interventions': [{'name': 'Volumetric Arc Radiotherapy', 'type': 'RADIATION', 'description': 'Volumetric Arc Radiotherapy', 'armGroupLabels': ['Classical treatment', 'GemInterBraVMAT']}, {'name': 'Interstitial brachytherapy', 'type': 'RADIATION', 'description': 'Interstitial High Dose Rate Brachytherapy', 'armGroupLabels': ['GemInterBraVMAT']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['CDDP'], 'description': 'Weekly Cisplatin', 'armGroupLabels': ['Classical treatment', 'GemInterBraVMAT']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemcitabine Hydrochloride'], 'description': 'Weekly Gemcitabine', 'armGroupLabels': ['GemInterBraVMAT']}, {'name': 'PIK3CA', 'type': 'GENETIC', 'description': 'PIK3CA mutations rate', 'armGroupLabels': ['Classical treatment', 'GemInterBraVMAT']}, {'name': 'KRAS', 'type': 'GENETIC', 'description': 'KRAS mutations rate', 'armGroupLabels': ['Classical treatment', 'GemInterBraVMAT']}, {'name': 'BRAF', 'type': 'GENETIC', 'description': 'BRAF mutations rate', 'armGroupLabels': ['Classical treatment', 'GemInterBraVMAT']}, {'name': 'RRM1', 'type': 'GENETIC', 'description': 'RRM1 mutations rate', 'armGroupLabels': ['Classical treatment', 'GemInterBraVMAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AZ1011', 'city': 'Baku', 'state': 'Baku', 'status': 'RECRUITING', 'country': 'Azerbaijan', 'contacts': [{'name': 'Aziz Aliyev, Professor', 'role': 'CONTACT', 'email': 'internationalnoc@gmail.com', 'phone': '+994504807021'}], 'facility': 'National Center of Oncology', 'geoPoint': {'lat': 40.37767, 'lon': 49.89201}}], 'centralContacts': [{'name': 'Kamal Akbarov, PhD', 'role': 'CONTACT', 'email': 'akperovkamal@yahoo.com', 'phone': '+994503362974'}], 'overallOfficials': [{'name': 'Kamal Akbarov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The National Center of Oncology, Azerbaijan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist, PhD', 'investigatorFullName': 'Kamal Akbarov', 'investigatorAffiliation': 'The National Center of Oncology, Azerbaijan'}}}}