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

Phase 2

Terminated

• Conditions: Locally Advanced Cervical Cancer
• Interventions: Radiation: SABR Boost Therapy

• Registration Number: NCT02045433
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-03-27
• Primary Completion: 2018-11-04
• Study Completion: 2018-11-04
• Results First Submitted: 2019-03-14
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-16
• Results First Posted: 2019-10-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1 Locally Advanced stage Cervical Cancer 2. Zubrod performance status 0-2 3. Negative urine or serum pregnancy test for women of child-bearing potential 4. Agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment 5. Not a candidate for intracavitary brachytherapy

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Exclusion Criteria

1. Pregnancy
2. Concurrent untreated cancer excluding non-Melanoma skin cancer
3. Previous pelvic radiation
4. Active Inflammatory Bowel disease, Collagen vascular disease - systemic lupus erythematosus (SLE), scleroderma
5. Age <18
6. Unable to consent for study
7. Severely immunocompromised patients ( such as Transplant , on immunosuppressive drugs)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SABR Boost Therapy	SABR Boost Therapy	-

Primary Outcome Measures

Name	Time	Method
Time Taken to Induce Primary Tumor Control	2 years	The primary objective is to improve primary tumor local control of eligible LACC using SABR as the mechanism for delivering boost therapy to 85% at 2 years post treatment

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States