NCT02957266

Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy

Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: The National Center of Oncology, Azerbaijan · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Volumetric Arc Radiotherapy	Volumetric Arc Radiotherapy
RADIATION	Interstitial brachytherapy	Interstitial High Dose Rate Brachytherapy
DRUG	Cisplatin	Weekly Cisplatin
DRUG	Gemcitabine	Weekly Gemcitabine
GENETIC	PIK3CA	PIK3CA mutations rate
GENETIC	KRAS	KRAS mutations rate
GENETIC	BRAF	BRAF mutations rate
GENETIC	RRM1	RRM1 mutations rate

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-12-01
• Completion: 2020-12-01
• First posted: 2016-11-07
• Last updated: 2016-11-15

Locations

1 site across 1 country: Azerbaijan