NCT02045433

Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer

A Phase II Study for Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether SABR boost therapy is effective in women with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI) or genitourinary (GU) toxicity.

Detailed description

Patients enrolled in this study will receive 45 Gray (Gy) in 25 fractions of intensity modulated external beam radiation therapy + weekly cisplatinum . Following the completion of Intensity Modulated Radiation Therapy (IMRT), patients will receive 28 Gy in 4 fractions using stereotactic body radiation therapy techniques.

Conditions

• Locally Advanced Cervical Cancer

Interventions

Type	Name	Description
RADIATION	SABR Boost Therapy	1. Initial Pelvic (+/- Para-aortic) fractionated external beam Radiation with 45 Gy to combined PTV with a boost to 55Gy for PET positive/CT enlarged nodes; 2. Image Guided Hypofractionated Radiation Treatment boost to Cervix High risk CTV/PTV 28GY/4 fx. Patients will receive 4 fractions of 7 Gy each via stereotactic body radiation as boost therapy to a volume that encompasses the cervical tumor. A minimum of 40 hours should separate each treatment.

Timeline

• Start date: 2014-03-27
• Primary completion: 2018-11-04
• Completion: 2018-11-04
• First posted: 2014-01-24
• Last updated: 2020-08-21
• Results posted: 2019-10-08

Locations

1 site across 1 country: United States