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

Phase 3

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

• Registration Number: CTRI/2017/02/007934
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1050

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute benefit in local control rates by 10% for FIGO IIB and IIIBTimepoint: 7 years

Secondary Outcome Measures

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