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A Study To Evaluate Benefit and Risk Between Two Different Dose Schedule Of Internal Radiation Treatment In Cancer Cervix Patients

A Prospective Randomised Study To Evaluate Efficacy And Safety between Two Different Dose Fractionation Schedule Of Interstitial Brachytherapy In Treatment Of Patients With Carcinoma of Uterine Cervix

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051952
Enrollment
98
Registered
2023-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: C531- Malignant neoplasm of exocervix

Interventions

Intervention1: ISBT of dose 9 x 2: After EBRT patient will receive Interstitial brachytherapy of dose 9 Gy in 2 fractions Control Intervention1: ISBT of dose 7 x 3: After EBRT patient will receive Ins

Sponsors

SVIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histopathologically confirmed carcinoma of Uterine cervix Patients of age group 18 to 70 years. Patients with performance status of 0 to 2 Stage II B- III C with intact cervix. Patients with gross residual disease after EBRT not suitable for ICRT Distorted Geometry like narrow vagina and os not soundable Post hysterectomy Carcinoma vault Post supra cervical hysterectomy with carcinoma of cervical stump. Extensive para vaginal and distal vaginal involvement Patients who has given approved informed consent Post EBRT parametrial involvement of more than medial one third

Exclusion criteria

Exclusion criteria: Patients with distant metastasis Patients with prior EBRT and Brachytherapy to pelvis Patients with ECOG performance status of 3-4 Pregnant women and lactating mothers Patients who has not given informed consent

Design outcomes

Primary

MeasureTime frame
Tumour ResponseTimepoint: 6 months

Secondary

MeasureTime frame
Proctitis and CystitisTimepoint: 6 months

Countries

India

Contacts

Public ContactHenita Selvamary

Sri Venkateswara Institute of Medical Sciences

drpranabandhu79@gmail.com9443861325

Outcome results

None listed

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