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A study to compare two different doses of brachytherapy in endometrial cancer

A prospective randomized control study to compare the effect of two dose schedules used for vault brachytherapy in intermediate risk groups of endometrial cancer.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041034
Enrollment
400
Registered
2022-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C541- Malignant neoplasm of endometrium

Interventions

Intervention1: vault brachytherapy: 5Gy HDR per fraction for 5 fractions to be treated daily for 5 consecutive days Control Intervention1: Vault brachytherapy: 7Gy HDR per fraction for 3 fractions, on

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. ECOG 0-1 3. Histologically confirmed cases of Endometroid endometrial carcinoma

Exclusion criteria

Exclusion criteria: 1. Poor performance status 2. Serous or clear cell carcinoma endometrium, sarcoma or carcinosarcoma 3. Stage >1, stage 1a grade 1 4. Uncontrolled Comorbidities 5. No prior history of pelvic radiotherapy 6. Residual macroscopic disease

Design outcomes

Primary

MeasureTime frame
To compare the outcome (local control) of vault brachytherapy schedules of 5 Gy x 5 fractions over a week and 7 Gy in 3# in intermediate group endometrial carcinoma. To compare the toxicities of different brachytherapy schedules in endometrial cancers. Timepoint: Base line, at 3 month first followup, 6 month, 9 month, 12 month, 24 month, 36 month, 48month

Secondary

MeasureTime frame
To compare health related quality of life To evaluate Overall survival and failure free survival Timepoint: Assess quality of life: at 3 month, 6 month, 9 month, 12 month, 2 years, 3 years Assess the overall survival till death and failure free survival till disease recures

Countries

India

Contacts

Public ContactSrinivasa G Y

Post Graduate Institute Of Medical Education and Research

drsrinivasagowda@gmail.com9805803262

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026