A Randomised Controlled Trial Between Two Different HDR Brachytherapy Schedule in Locally Advanced Carcinoma of Uterine Cervix

Phase 3

Completed

• Conditions: Squamous Cell Carcinoma of Cervix
• Interventions: Radiation: HDR Brachytherapy of 9 Gy in 2 fractions; Radiation: HDR Brachytherapy of 7 Gy in 3 fractions

• Registration Number: NCT02765919
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

The purpose of this study is to compare two different brachytherapy treatment option in locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is effective in locoregional control and more convenient in terms of cost and time than 7 Gy brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.

Detailed Description

Cervical cancer is the second most common cancer among women worldwide and is the commonest form of gynecolgic malignancy in Bangladesh.Radiotherapy in the form of external beam radiotherapy combined with intracavitary Brachytherapy is the accepted definitive mode of treatment.Limiting the number of high dose rate(HDR) Brachytherapy has the potential benefit of improving patient compliance and reducing treatment cost and duration.The aim of this study is to compare the treatment outcome and acute complications following treatment with 9 Gray (Gy) in two fractions of brachytherapy with standard EBRT in locally advanced carcinoma of cervix.

EBRT will be delivered by a cobalt 60 teletherapy unit to a prescribed dose of 50 Gy in 25 fractions of 2 Gy per fraction and 5 days a week over a period of 5 weeks concurrent with inj. Cisplatin 40 mg/meter square weekly for 5 weeks.The patients will be then randomised into two arms of HDR brachytherapy,either 9Gy in 2 fractions or 7 Gy in 3 fractions.All patients will be followed up as per guideline for 6 months.The treatment related toxicity will be measured by Common Toxicity Criteria(Common terminology criteria for adverse events v.3.0).

All the relevant collected data will be compiled on a master chart and then statistical analysis of the results will be obtained by using SPSS 17.The data will be analysed using Chi square test and T test.Significant value will be decided at a level of 0.05 in two tailed tests.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Primary Completion: 2016-12
• Study Completion: 2017-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Locally advanced carcinoma cervix (stage 2b - 4a)
• Histopathology squamous cell carcinoma

Exclusion Criteria

• Previous history of malignancy
• Previously treated with radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiation HDR Brachytherapy 9 Gy	HDR Brachytherapy of 9 Gy in 2 fractions	High dose rate (HDR) Brachytherapy of weekly 9 Gray in two fractions in two weeks after 50 Gray of EBRT in 2 Gray per fraction of 5 weeks with chemotherapy cisplatin 40 mg /m2 weekly for five weeks in locally advanced carcinoma cervix
Radiation HDR Brachytherapy 7 Gy	HDR Brachytherapy of 7 Gy in 3 fractions	High dose rate (HDR) brachytherapy of weekly 7 Gray in three fractions in three weeks after 50 Gray EBRT of 2 Gray per fraction of 25 fractions concurrently with weekly chemotherapy cisplatin40 mg /m2 in five weeks in locally advanced carcinoma cervix

Primary Outcome Measures

Name	Time	Method
Reduction of tumor size in cervix	Six month	Comparison of pre treatment tumor size with post treatment tumor

Trial Locations

Locations (1)

BSM Medical University; 🇧🇩 Dhaka, Bangladesh