Study to compare x ray and MRI based Brachytherapy in cervical cancer.

Conventional Radiography based BT (Controlled Arm) Vs MR-Image Based Brachytherapy (Study Arm) in Locally Advanced Cervical Cancers: A PHASE III Randomized Control Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/02/007934

Enrollment

1050

Registered

2017-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Cancer of the uterine cervix patient

Interventions

Intervention1: MR Image Based Brachytherapy: Treatment planning for MR Image Based Brachytherapy is based on gynaecological examination performed at the time of BT applicator implantation and MRI take

Eligibility

Inclusion criteria

Inclusion criteria: •Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo) therapy including MRI guided Brachytherapy. •Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. •Stage IIB/IIIB according to FIGO and TNM guidelines •Suitable for Brachytherapy boost •MRI of pelvis at diagnosis is performed •MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed to rule out para-aortic lymphnode metastasis. •Patient informed consent

Exclusion criteria

Exclusion criteria: 1.Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin. 2.Metastatic disease 3.Previous pelvic or abdominal radiotherapy 4.Previous total or partial hysterectomy 5.Combination of preoperative radiotherapy with surgery 6.Patients receiving BT only 7.Patients receiving EBRT only 8.Patients receiving neoadjuvant chemotherapy 9.Contra indications to MRI 10.Contra indications to BT 11.Active infection or severe medical condition endangering treatment delivery. 12.Pregnant, lactating or childbearing potential without adequate contraception

Design outcomes

Primary

Measure	Time frame
Absolute benefit in local control rates by 10% for FIGO IIB and IIIBTimepoint: 7 years	—

Secondary

Measure	Time frame
Reduction in grade 3/4 late toxicities from 10% to 5% (by 50%) Pelvic control rates Distant Failures Progression free & cause specific survival Overall survival QOL life scores Timepoint: 7 years	—

Countries

India

Contacts

Public ContactDr Umesh Mahantshetty

Tata Memorial Hospital

drumeshm@gmail.com02224177168

Outcome results

None listed

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