Asian Gynecological Brachytherapy Registry in Cervical Cancer

NCT07196033 | Recruiting

• 1 other identifier: 901113
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 5

Brief Summary

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. For 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. To 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.

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 IIB Cervical Cancer FIGO 2018; Stage IIA Cervical Cancer FIGO 2018

Keywords

Definitive chemo-radiation; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (6)

• To record and report techniques utilised for external radiation and report outcomes in reference to EBRT techniques and prescription.

  3 years

• To report utilisation rates of concurrent chemotherapy and report outcomes in reference to cumulative cisplatin dose delivered.

  3 years

• . To record and report on prevalent brachytherapy fractionation regimes across participating sites.

  3 years

• To record and report on overall treatment times for the management of cervical cancer.

  3 years

• 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.

  3 years

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients diagnosed with FIGO 2018 stage IB-IVA cervical cancer with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma histological subtype.
• Planned for treatment with definitive chemo-radiation and brachytherapy. (X- ray,CT, CT-Ultrasound or MRI based).

You may not qualify if:

• Neuroendocrine cancer of the cervix or other rare histology subtypes.
• Patients with metastatic cervix cancer and not planned for radical doses of pelvic RT/brachytherapy may be excluded.
• Patients undergoing postoperative RT or RT for recurrent disease should be excluded.

Sponsors & Collaborators

• Chiang Mai University, Thailand: collaborator
• Mahidol University: collaborator
• Gunma University: collaborator
• Juntendo University: collaborator
• Tata Memorial Hospital: lead

Study Sites (5)

Tata Memorial Center

Mumbai, Maharashtra, 400012, India

RECRUITING

Gunma University

Maebashi, Japan, Japan

NOT YET RECRUITING

Juntendo University

Tokyo, Japan, Japan

NOT YET RECRUITING

Mahidol University

Bangkok, Thailand, Thailand

NOT YET RECRUITING

Chiang Mai University

Chiang Mai, Thailand, Thailand

NOT YET RECRUITING

Related Publications (10)

• 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: 37694176 BACKGROUND

• 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: 21952319 BACKGROUND

• 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: 30085892 BACKGROUND

• 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: 29280456 BACKGROUND

• 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: 35446962 BACKGROUND

• 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: 33794207 BACKGROUND

• 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: 22277978 BACKGROUND

• 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: 35719089 BACKGROUND

• 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: 36528031 BACKGROUND

• 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.

  PMID: 36599120 BACKGROUND

Central Study Contacts

Dr. Supriya Chopra

CONTACT

9930958309; supriyasastri@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Supriya Chopra

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): May 20, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); JP (2); TH (2)