COMPARATIVE STUDY BETWEEN TWO TYPES OF APPLICATORS IN THE BRACHYTHERAPY TREATMENT OF CARCINOMA CERVIX

DOSIMETRY AND CLINICAL OUTCOMES OF TANDEM RING VERSUS TANDEM OVOIDS INTRACAVITARY BRACHYTHERAPY APPLICATORS IN THE TREATMENT OF CARCINOMA CERVIX - A RANDOMISED STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052372

Enrollment

166

Registered

2023-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: C53- Malignant neoplasm of cervix uteri

Interventions

Intervention1: TANDEM RING APPLICATOR: HDR ICBT TO HR-CTV WITH A DOSE OF 7 GY PER FRACTION @ 2 FRACTIONS PER WEEK FOR A TOTAL OF 4 FRACTIONS - UPTO A DURATION OF 1 AND A HALF YEARS Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven carcinoma cervix patients 2. FIGO stage IB3, II, III 3. ECOG PSS 0-2 4. Patients who have completed a planned EBRT schedule of atleast 15# and are candidates of either T-O or T-R ICBT 5. Patients who have given approval for written informed consent

Exclusion criteria

Exclusion criteria: 1. ECOG PSS 3-4 2. Post operative carcinoma cervix patients 3. Carcinoma cervix with distant metastasis, RVF, VVF 4. Pregnant and lactating mothers

Design outcomes

Primary

Measure	Time frame
Dose received by two centimetre cube volume (D2cc) of rectum for two applicatorsTimepoint: 1 YEAR	—

Secondary

Measure	Time frame
Doses received by 90% and 98% of HR-CTV and D2cc bladder, D2cc sigmoid colon Tumor response Acute bladder and rectal toxicities Late bladder and rectal toxicitiesTimepoint: 1 year	—

Countries

India

Contacts

Public ContactDr B Sreenivasa Rao

Sri Venkateswara Institute of Medical Sciences

doctorrt12@gmail.com9701951615

Outcome results

None listed

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