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

NCT02045433 | Terminated Phase 2 Results DMC

• 1 other identifier: STU 082013-064
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Time Taken to Induce Primary Tumor Control

  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

  2 years

Study Arms (1)

SABR Boost Therapy

EXPERIMENTAL

Radiation: SABR Boost Therapy

Interventions

SABR Boost Therapy RADIATION

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.

SABR Boost Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Limitations and Caveats

Study was not completed .the total number of accrual was not met

Results Point of Contact

• Title: Dr.Kevin Albuquerque
• Organization: UT Southwestern/Simmons Cancer Center-Dallas

Kevin.Albuquerque@UTSouthwestern.edu

2146458499

Study Officials

• Kevin Albuquerque, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 24, 2014
• Study Start: March 27, 2014
• Primary Completion: November 4, 2018
• Study Completion: November 4, 2018
• Last Updated: August 21, 2020
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Locations

US (1)