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

Squamous Cell Carcinoma of Cervix Clinical Trial

Official title:

Study of Two Fractions Versus Three Fractions High Dose Rate Brachytherapy in Locally Advanced Carcinoma of Uterine Cervix After Pelvic Concurrent Chemoradiotherapy - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765919
• Other study ID #: 1356
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

• Histopathology squamous cell carcinoma

Exclusion Criteria:

• Previous history of malignancy

• Previously treated with radiotherapy

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Cervix

Intervention

Radiation:
• HDR Brachytherapy of 9 Gy in 2 fractions
Two fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
• HDR Brachytherapy of 7 Gy in 3 fractions
Three fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix

Locations

Country	Name	City	State
Bangladesh	BSM Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (1)

Patel FD, Rai B, Mallick I, Sharma SC. High-dose-rate brachytherapy in uterine cervical carcinoma. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):125-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of tumor size in cervix	Comparison of pre treatment tumor size with post treatment tumor	Six month

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