Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT07196033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asian Gynecological Brachytherapy Registry in Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recording and reporting the prevalent practices of cervical cancer brachytherapy in the management of cervical cancer in FARO member countries and report outcomes in reference to techniques utilised.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'To record and report techniques utilised for external radiation and report outcomes in reference to EBRT techniques and prescription.', 'timeFrame': '3 years'}, {'measure': 'To report utilisation rates of concurrent chemotherapy and report outcomes in reference to cumulative cisplatin dose delivered.', 'timeFrame': '3 years'}, {'measure': '. To record and report on prevalent brachytherapy fractionation regimes across participating sites.', 'timeFrame': '3 years'}, {'measure': 'To record and report on overall treatment times for the management of cervical cancer.', 'timeFrame': '3 years'}, {'measure': 'To report 2-yearlocal control, regional control and disease-free survival in reference to primary and nodal dose and chemotherapy dose in different subcohorts of cervical cancer.', 'timeFrame': '3 years'}, {'measure': 'To report 2-year gastrointestinal, genitourinary, hematological and vaginal adverse events with use of radiation and brachytherapy using CTCAE version 5.0', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Definitive chemo-radiation', 'Brachytherapy'], 'conditions': ['Stage IIIA Cervical Cancer FIGO 2018', 'Stage IIIB Cervical Cancer FIGO 2018', 'Stage IVA Cervical Cancer FIGO 2018', 'Stage IB Cervical Cancer FIGO 2018', 'Stage IIA Cervical Cancer FIGO 2018', 'Stage IIB Cervical Cancer FIGO 2018']}, 'referencesModule': {'references': [{'pmid': '37694176', 'type': 'BACKGROUND', 'citation': 'Hande V, Chopra S, Polo A, Mittal P, Kohle S, Ghadi Y, Mulani J, Gupta A, Kinhikar R, Agarwal JP. Transitioning India to advanced image based adaptive brachytherapy: a national impact analysis of upgrading National Cancer Grid cervix cancer guidelines. Lancet Reg Health Southeast Asia. 2023 Jun 6;16:100218. doi: 10.1016/j.lansea.2023.100218. eCollection 2023 Sep.'}, {'pmid': '21952319', 'type': 'BACKGROUND', 'citation': "Tharavichitkul E, Mayurasakorn S, Lorvidhaya V, Sukthomya V, Wanwilairat S, Lookaew S, Pukanhaphan N, Chitapanarux I, Galalae R. Preliminary results of conformal computed tomography (CT)-based intracavitary brachytherapy (ICBT) for locally advanced cervical cancer: a single institution's experience. J Radiat Res. 2011;52(5):634-40. doi: 10.1269/jrr.10154."}, {'pmid': '30085892', 'type': 'BACKGROUND', 'citation': 'Mittal P, Chopra S, Pant S, Mahantshetty U, Engineer R, Ghosh J, Gupta S, Ghadi Y, Menachery S, Swamidas J, Gurram L, Shrivastava SK. Standard Chemoradiation and Conventional Brachytherapy for Locally Advanced Cervical Cancer: Is It Still Applicable in the Era of Magnetic Resonance-Based Brachytherapy? J Glob Oncol. 2018 Jul;4:1-9. doi: 10.1200/JGO.18.00028.'}, {'pmid': '29280456', 'type': 'BACKGROUND', 'citation': 'Mahantshetty U, Krishnatry R, Hande V, Jamema S, Ghadi Y, Engineer R, Chopra S, Gurram L, Deshpande D, Shrviastava S. Magnetic Resonance Image Guided Adaptive Brachytherapy in Locally Advanced Cervical Cancer: An Experience From a Tertiary Cancer Center in a Low and Middle Income Countries Setting. Int J Radiat Oncol Biol Phys. 2017 Nov 1;99(3):608-617. doi: 10.1016/j.ijrobp.2017.06.010. Epub 2017 Jun 20.'}, {'pmid': '35446962', 'type': 'BACKGROUND', 'citation': 'Murakami N, Ando K, Murata M, Murata K, Ohno T, Aoshika T, Kato S, Okonogi N, Saito AI, Kim JY, Yoshioka Y, Sekii S, Tsujino K, Lowanichkiattikul C, Pattaranutaporn P, Kaneyasu Y, Nakagawa T, Watanabe M, Uno T, Umezawa R, Jingu K, Kanemoto A, Wakatsuki M, Shirai K, Igaki H, Itami J. An Asian multi-national multi-institutional retrospective study comparing intracavitary versus the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical carcinoma. J Radiat Res. 2022 May 18;63(3):412-427. doi: 10.1093/jrr/rrac014.'}, {'pmid': '33794207', 'type': 'BACKGROUND', 'citation': 'Potter R, Tanderup K, Schmid MP, Jurgenliemk-Schulz I, Haie-Meder C, Fokdal LU, Sturdza AE, Hoskin P, Mahantshetty U, Segedin B, Bruheim K, Huang F, Rai B, Cooper R, van der Steen-Banasik E, Van Limbergen E, Pieters BR, Tan LT, Nout RA, De Leeuw AAC, Ristl R, Petric P, Nesvacil N, Kirchheiner K, Kirisits C, Lindegaard JC; EMBRACE Collaborative Group. MRI-guided adaptive brachytherapy in locally advanced cervical cancer (EMBRACE-I): a multicentre prospective cohort study. Lancet Oncol. 2021 Apr;22(4):538-547. doi: 10.1016/S1470-2045(20)30753-1.'}, {'pmid': '22277978', 'type': 'BACKGROUND', 'citation': 'Tharavichitkul E, Sivasomboon C, Wanwilairat S, Lorvidhaya V, Sukthomya V, Chakrabhandu S, Lookkaew S, Chitapanarux I, Galalae R. Preliminary results of MRI-guided brachytherapy in cervical carcinoma: the Chiangmai University experience. J Radiat Res. 2012;53(2):313-8. doi: 10.1269/jrr.11107. Epub 2012 Jan 21.'}, {'pmid': '35719089', 'type': 'BACKGROUND', 'citation': "Tharavichitkul E, Jia-Mahasap B, Muangwong P, Chakrabandhu S, Klunklin P, Onchan W, Tippanya D, Nobnop W, Watcharawipha A, Kittidachanan K, Galalae RM, Chitapanarux I. Survival outcome of cervical cancer patients treated by image-guided brachytherapy: a 'real world' single center experience in Thailand from 2008 to 2018. J Radiat Res. 2022 Jul 19;63(4):657-665. doi: 10.1093/jrr/rrac025."}, {'pmid': '36528031', 'type': 'BACKGROUND', 'citation': 'Singh D, Vignat J, Lorenzoni V, Eslahi M, Ginsburg O, Lauby-Secretan B, Arbyn M, Basu P, Bray F, Vaccarella S. Global estimates of incidence and mortality of cervical cancer in 2020: a baseline analysis of the WHO Global Cervical Cancer Elimination Initiative. Lancet Glob Health. 2023 Feb;11(2):e197-e206. doi: 10.1016/S2214-109X(22)00501-0. Epub 2022 Dec 14.'}, {'pmid': '36599120', 'type': 'BACKGROUND', 'citation': 'Schmid MP, Lindegaard JC, Mahantshetty U, Tanderup K, Jurgenliemk-Schulz I, Haie-Meder C, Fokdal LU, Sturdza A, Hoskin P, Segedin B, Bruheim K, Huang F, Rai B, Cooper R, van der Steen-Banasik E, Van Limbergen E, Pieters BR, Petric P, Ramazanova D, Ristl R, Kannan S, Hawaldar R, Ecker S, Kirchheiner K, Tan LT, Nout R, Nesvacil N, de Leeuw A, Potter R, Kirisits C; EMBRACE Collaborative Group. Risk Factors for Local Failure Following Chemoradiation and Magnetic Resonance Image-Guided Brachytherapy in Locally Advanced Cervical Cancer: Results From the EMBRACE-I Study. J Clin Oncol. 2023 Apr 1;41(10):1933-1942. doi: 10.1200/JCO.22.01096. Epub 2023 Jan 4.'}]}, 'descriptionModule': {'briefSummary': "Gynecological cancer poses as significant public health issue, especially in Asian countries, where it is a leading cause of cancer-related deaths among women. Cervical cancer accounts for around 311,000 deaths annually, with over 85% occurring in low- and middle-income nations, primarily in Asia. Factors contributing to this burden include limited access to preventive care, inadequate screening, high rates of human papillomavirus infection, and cultural barriers that delay medical attention.\n\nFor patients with advanced cervical cancer, the standard treatment involves external beam radiation therapy along with chemotherapy followed by internal radiation, known as Brachytherapy. This technique uses unique set of devices placed internally at the tumor sitegiving localized radiation to the residual tumor tissue. While advanced brachytherapy techniques have been developed and practiced in Europe and American countries yielding excellent clinical outcomes, there is insufficient data on the use and results of such advanced brachytherapy techniques in Asian populations, leading to a lack of standardized practices.\n\nTo address these issues, the Asian Gynecological Brachytherapy Registry (ABGR) has been established as a collaborative platform for data collection and analysis on the use of Brachytherapy techniques. This registry aims to consolidate information from various healthcare settings across Asia, enhancing understanding of cervical cancer's epidemiology, evaluating treatment effectiveness, and identifying areas for improvement in patient care.", 'detailedDescription': 'The registry will follow a retrospective cohort study design by including consecutive patients treated in participating institutions over a 12-month period. It encompasses patients receiving various levels of brachytherapy, including 2D to 3D modalities, and considers different imaging techniques for treatment planning. Contouring variability and patient demographics are also accounted to ensure a comprehensive understanding of real-world application. With a target enrolment of 1,000 patients across multiple centres in FARO member countries, the AGBR aims to capture diverse patient environments and institutional practices. Through this collaborative effort, it seeks to report on different brachytherapy utilization patterns, clinical outcomes, and factors influencing treatment decisions and disparities. Additionally, information related to external radiation, administration of concurrent chemotherapy and overall treatment time will also be captured. Taken together these 3 components and timely administration of treatment constitute pillars of successful and effective treatment for cervix cancer. Administratively, data handling and storage protocols built in protocol will safeguard patient privacy and data integrity. Monitoring and quality assurance processes ensure data completeness and accuracy, while a publication policy promotes transparent dissemination of research findings, prioritizing multi-institutional collaborations and publishing in this domain from Asia.In conclusion, the AGBR once completed will represent a collaborative effort to address the variations in cervical cancer treatment in Asia and provide baseline data for future prospective work.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is diagnosed with FIGO 2018 stage IB-IVA cervical cancer with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma histological subtype and have undergone treatment with definitive chemo-radiation and brachytherapy (X-ray, CT, CT-Ultrasound or MRI based) for cervical cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with FIGO 2018 stage IB-IVA cervical cancer with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma histological subtype.\n* Planned for treatment with definitive chemo-radiation and brachytherapy. (X- ray,CT, CT-Ultrasound or MRI based).\n\nExclusion Criteria:\n\n* Neuroendocrine cancer of the cervix or other rare histology subtypes.\n* Patients with metastatic cervix cancer and not planned for radical doses of pelvic RT/brachytherapy may be excluded.\n* Patients undergoing postoperative RT or RT for recurrent disease should be excluded.'}, 'identificationModule': {'nctId': 'NCT07196033', 'acronym': 'AGBR-FERN-Gyn', 'briefTitle': 'Asian Gynecological Brachytherapy Registry in Cervical Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tata Memorial Hospital'}, 'officialTitle': 'Asian Gynecological Brachytherapy Registry in Cervical Cancer', 'orgStudyIdInfo': {'id': '901113'}}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'contacts': [{'name': 'Dr. Supriya Chopra', 'role': 'CONTACT', 'email': 'supriyasastri@gmail.com', 'phone': '9930958309'}], 'facility': 'Tata Memorial Center', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Maebashi', 'state': 'Japan', 'country': 'Japan', 'contacts': [{'name': 'Dr. Tatsuyo Ohno', 'role': 'CONTACT', 'email': 'tohno@gunma-u.ac.jp', 'phone': '0'}], 'facility': 'Gunma University', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Tokyo', 'state': 'Japan', 'country': 'Japan', 'contacts': [{'name': 'Dr. Noriyuki Okonogi', 'role': 'CONTACT', 'email': 'n.okonogi.rd@juntendo.ac.jp', 'phone': '0'}], 'facility': 'Juntendo University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Bangkok', 'state': 'Thailand', 'country': 'Thailand', 'contacts': [{'name': 'Dr. Chairat Lowanichkiattikul', 'role': 'CONTACT', 'email': 'chairat.lowa@gmail.com', 'phone': '0'}], 'facility': 'Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'state': 'Thailand', 'country': 'Thailand', 'contacts': [{'name': 'Dr. Ekkasit Tharavichitkul', 'role': 'CONTACT', 'email': 'etharavichitkul@gmail.com', 'phone': '0'}], 'facility': 'Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Dr. Supriya Chopra', 'role': 'CONTACT', 'email': 'supriyasastri@gmail.com', 'phone': '9930958309'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Chiang Mai University, Thailand', 'class': 'UNKNOWN'}, {'name': 'Mahidol University', 'class': 'OTHER'}, {'name': 'Gunma University', 'class': 'OTHER'}, {'name': 'Juntendo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Supriya Chopra', 'investigatorFullName': 'Supriya Sastri (chopra)', 'investigatorAffiliation': 'Tata Memorial Hospital'}}}}