Asian Gynecological Brachytherapy Registry in Cervical Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorTata Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

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Tata Memorial Hospital

Lead sponsor

Chiang Mai University, Thailand

Collaborator

Mahidol University

Collaborator

Gunma University

Collaborator

Juntendo University

Collaborator