Clinical trial NCT02765919: A Randomised Controlled Trial Between Two Different HDR Brachytherapy Schedule in Locally Advanced Carcinoma of Uterine Cervix
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of Cervix
Keywords: Carcinoma cervix
RCT(randomised controlled trial)
9 Gray
Brachytherapy
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous history of malignancy
* Previously treated with radiotherapy

Primary outcomes:
measure: Reduction of tumor size in cervix
timeFrame: Six month
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BSM Medical University
Study officials:
affiliation: Associate Professor,dept.of Oncology,BSMMU
name: Mohammad Abdul Bari, MBBS,MPhil
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.ijrobp.2004.09.017.