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
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02879214 -
Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer
|
Phase 2 |