Short course external beam radio-chemotherapy and single application brachytherapy for cervical cancer – a Phase II study

Short course Image guided external beam radio-chemotherapy and single application Magnetic resonance imaging guided BRAchytherapy for CErvical cancer – a Phase II study - SIMBRACE - II

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033538

Enrollment

102

Registered

2021-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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: Short Course Image Guided External Beam Radio-chemotherapy and Single Application Magnetic Resonance Imaging Guided HDR Brachytherapy: All patients will receive concurrent chemotherapy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women = 18 years of age 2. Histologically proven invasive cancer of the uterine cervix - squamous cell carcinoma, adenocarcinoma or adeno-squamous carcinoma. 3. FIGO 2018 stages IB2-IIIC1 patients after clinical examination and imaging. 4. Those who provide willingness to consent for participation in trial and follow up

Exclusion criteria

Exclusion criteria: 1) Patients with radiological FIGO Stage IIIC2 disease (involved para-aortic lymph nodes above the bifurcation of aorta) 2) Patients with recurrent cervical cancers. 3) Previous history of abdominal or pelvic radiation. 4) Previous history of hysterectomy or major abdominopelvic surgery. 5) History of connective tissue disorders.6) Patients with contra-indications to undergo MR imaging (metallic prosthesis, severe claustrophobia etc). 7) Patients with lymph nodes > 3cm in size 8) Patients who receive neo-adjuvant chemotherapy 9) Medical or psychological illness precluding treatment protocol (including renal / hepatic dysfunction, significant cardiac co-morbidities etc, which may preclude delivery of adequate doses of chemotherapy). 10) Pregnant and breast feeding women.

Design outcomes

Primary

Measure	Time frame
Pelvic Control (local + regional pelvic nodal)Timepoint: 3 years	—

Secondary

Measure	Time frame
Acute GU, GI and vaginal toxicities (Grade = 3).Timepoint: 6 weeks;Late GU, GI and vaginal toxicities (Grade = 3).Timepoint: 3 years	—

Countries

India

Contacts

Public ContactDr Raviteja Miriyala

Homi Bhabha Cancer Hospital and Research Centre (unit of Tata Memorial Centre)

drumeshm@gmail.com09819885774

Outcome results

None listed

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