SINGLE SESSION IMAGE-BASED INTRACAVITARY BRACHYTHERAPY FOR LOCALLY ADVANCED CERVICAL CANCER

MULTIPLE SESSIONS VERSUS SINGLE SESSION IMAGE-BASED INTRACAVITARY BRACHYTHERAPY FOR LOCALLY ADVANCED CERVICAL CANCER -- A RANDOMISED CONTROLLED TRIAL - SABICECA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/037837

Enrollment

Registered

2021-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri

Interventions

Intervention1: HDR BRACHYTHERAPY: It will consist of External Beam Radiotherapy (EBRT) to pelvis at a dose of 50.4 Gy/ 28 fractions over 5.5 weeks at 1.8Gy per fraction with weekly concurrent cisplati

Eligibility

Inclusion criteria

Inclusion criteria: 1.Biopsy-proven carcinoma of cervix (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma) 2.Age from 18 to 65 years 3.International Federation of Gynaecology and Obstetrics (FIGO) stage IIB-IIIC1 after thorough clinical examination and investigation 4.Suitable for radical radiation therapy with or without chemotherapy and for brachytherapy boost 5.Karnofsky performance scale score of 70 and above 6.Patients who have given informed consent

Exclusion criteria

Exclusion criteria: 1.Patients at high risk of anaesthesia and patients with phobia/contra-indications to undergo MRI/CT 2.Intracavitary application not feasible 3.Previous oncologic therapy with surgery, radiotherapy or chemotherapy 4.Uncontrolled co-morbid conditions e.g. Hypertension, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease (COPD), Coronary Artery Disease (CAD) 5.Pregnancy 6.Deranged renal, liver function test

Design outcomes

Primary

Measure	Time frame
1.To compare acute toxicity in the patients of locally advanced cervical cancer treated with weekly multiple applications vs single application of image guided intracavitary HDR brachytherapy after EBRT. 2.To compare the loco-regional control of cancer after 6 months in the two arms. Timepoint: 1.To compare acute toxicity in the patients of locally advanced cervical cancer treated with weekly multiple applications vs single application of image guided intracavitary HDR brachytherapy after EBRT. 2.To compare the loco-regional control of cancer after 6 months in the two arms.	—

Measure

Time frame

1.To compare acute toxicity in the patients of locally advanced cervical cancer treated with weekly multiple applications vs single application of image guided intracavitary HDR brachytherapy after EBRT. 2.To compare the loco-regional control of cancer after 6 months in the two arms. Timepoint: 1.To compare acute toxicity in the patients of locally advanced cervical cancer treated with weekly multiple applications vs single application of image guided intracavitary HDR brachytherapy after EBRT. 2.To compare the loco-regional control of cancer after 6 months in the two arms.

—

Secondary

Measure	Time frame
To compare the loco-regional control of cancer after 6 months in the two arms. Timepoint: 6 MONTHS	—

Countries

India

Contacts

Public ContactDR SUSHANT

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

sharmadnaiims@gmail.com9868969899

Outcome results

None listed

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