- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SABR Boost Therapy
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Taken to Induce Primary Tumor Control
Time Frame: 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
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin Albuquerque, M.D., University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 082013-064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Washington University School of MedicineNational Cancer Institute (NCI)RecruitingCervical Cancer | Pancreatic Cancer | Pancreas Cancer | Locally Advanced Cervical Carcinoma | Locally Advanced Cervical Cancer | Cancer of the Pancreas | Locally Advanced Pancreatic Carcinoma | Locally Advanced Pancreatic Cancer | Cancer of the Cervix | Locally Advanced Pancreas CancerUnited States
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