The purpose of this study is to define an effectiveness of concurrent chemoradiotherapy of cervical cancer patients treated by VMAT (volumetric arc therapy) based external beam radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial brachytherapy.
Now cisplatin based concurrent chemoradiotherapy for cervical cancer is a standard treatment modality. But we consider that the treatment results could be improved by several ways: 1. use of VMAT (volumetric arc therapy) based external beam radiotherapy could decrease toxicity by reducing of unnecessarily irradiated tissue volumes; 2. in addition to cisplatin gemcitabine could enhance tumor cell damaging effect of radiation; 3. interstitial brachytherapy could provide higher radiation dose boost to high risk tumor volume while sparing surrounding organs at risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Volumetric Arc Radiotherapy
Interstitial High Dose Rate Brachytherapy
Weekly Cisplatin
National Center of Oncology
Baku, Baku City, Azerbaijan
RECRUITINGRelapse Rate (local and/or distant) and Number of Deaths Due to Any Cause
Time frame: 4 years
Number of Participants With Progressive Disease
Time frame: 4 years
Incidence of acute toxicity
Time frame: Up to 30 days after completion of radiation therapy
Incidence of late toxicity
Time frame: Up to 2 years after completion of radiation therapy
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Weekly Gemcitabine
PIK3CA mutations rate
KRAS mutations rate
BRAF mutations rate
RRM1 mutations rate