A study assessing treatment outcomes of single-application internal radiation therapy delivering multiple sessions of tratemnt along with chemotherapy and external radiation in women with cervical cancer

Multifractionated high dose rate brachytherapy with single application along with concurrent external beam chemoradiotherapy in definitive management of carcinoma of uterine cervix: Phase II Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103010

Enrollment

Registered

2026-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: Delivery of multiple fractions of brachytherapy follwing single application of intracavitary brachytherapy application in carcinoma of uterine cervix: Patients will undergo external bea

one fraction daily) concurrent weekly cisplatin 40mg/ m2 followed by image guided ICBT in 4 fractions (7 Gray per fraction). Patients with IIIC1 would be treated with 45 Gray in 25 fractions to whole

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years. 2. Histologically proven squamous carcinoma of the uterine cervix of FIGO (2018) stage IB2-IIIC2 3. Patients being treated definitively with radiotherapy 4. Patient willing to sign the informed consent. 5. KPS more than equal to 70 6. Normal complete blood counts, kidney, liver function tests

Exclusion criteria

Exclusion criteria: 1. Stage IV disease 2. History of any other malignancy within the last 5 years 3. Adenocarcinoma of the cervix 4. Patient suffering from active HIV, Hepatitis B or C. 5. Pregnancy or lactating women 6. Patients not meeting the dosimetric constraints at the time of brachytherapy planning [EQD2 of the combined EBRT and ICBT for D90 of HR-CTV, D2cc of rectum, bladder and sigmoid would be recorded and it would be kept greater than or equal to 80-85 Gray, less than or equal to 65-75 Gy for rectum/sigmoid and less than or equal to 80-85 Gy for the bladder, respectively]

Design outcomes

Primary

Measure	Time frame
To assess the feasibility of this treatment schedule in terms of achieving dosimetric constraints 2.To evaluate the efficacy in terms of loco-regional controlTimepoint: 6 months	—

Secondary

Measure	Time frame
To evaluate the tolerability in terms of acute and late radiation toxicities.Timepoint: 0-12 months	—

Countries

India

Contacts

Public ContactDr Ajeet Kumar Gandhi

Dr Ram Manohar Lohia Institute of Medical Sciences

ajeetgandhi23@gmail.com9140284994

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026