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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02045433
Other study ID # STU 082013-064
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 27, 2014
Est. completion date November 4, 2018

Study information

Verified date September 2019
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date November 4, 2018
Est. primary completion date November 4, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

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)

Study Design


Intervention

Radiation:
SABR Boost Therapy
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; 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.

Locations

Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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