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NCT Number: NCT07196033

Asian Gynecological Brachytherapy Registry in Cervical Cancer

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.

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Key information

Conditions

Stage IIIA Cervical Cancer FIGO 2018 Stage IB Cervical Cancer FIGO 2018 Stage IIA Cervical Cancer FIGO 2018 Stage IIB Cervical Cancer FIGO 2018 Stage IIIB Cervical Cancer FIGO 2018 Stage IVA Cervical Cancer FIGO 2018

Sex eligibility

Female

Study type

Observational

Primary location

Tata Memorial Center, Mumbai, Maharashtra, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

  5. 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.

    Time frame: 3 years

  6. To report 2-year gastrointestinal, genitourinary, hematological and vaginal adverse events with use of radiation and brachytherapy using CTCAE version 5.0

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Supriya Chopra

CONTACT

[email protected]

9930958309

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Collaborators

  • Chiang Mai University, Thailand
  • Gunma University
  • Juntendo University
  • Mahidol University

Registry information

Acronym: AGBR-FERN-Gyn

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 29, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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