Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SABR Boost Therapy
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
- Principal Investigator: Kevin Albuquerque, M.D., University of Texas Southwestern Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- STU 082013-064
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SABR Boost Therapy |
|---|---|
| Arm/Group Description | SABR Boost Therapy for cervix cancer |
| Period Title: Overall Study | |
| STARTED | 16 |
| COMPLETED | 15 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Image Guided Hypfractioned Radiation Treatment |
|---|---|
| Arm/Group Description | Typically, only 1-5 fractions are used for Image Guided Hypofractionated RadiationTreatment depending on the tolerance of adjacent or intervening normal tissues. Linear structures (like the spinal cord) and tubular structures (like the bowels) are commonly called "serially functioning tissues" akin to series electrical circuits because their function is disrupted if there is a defect anywhere along their pathways. |
| Overall Participants | 16 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
12
75%
|
| >=65 years |
4
25%
|
| Sex/Gender, Customized (Count of Participants) | |
| Female participants |
16
100%
|
| male participants |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
6.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
25%
|
| White |
11
68.8%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
16
100%
|
Outcome Measures
| Title | Time Taken to Induce Primary Tumor Control |
|---|---|
| Description | 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 |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SABR Boost Therapy |
|---|---|
| Arm/Group Description | SABR Boost Therapy |
| Measure Participants | 16 |
| Median (95% Confidence Interval) [daya] |
55
|
Adverse Events
| Time Frame | The AE's were collected up to 90 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | SABR Boost Therapy | |
| Arm/Group Description | SABR Boost Therapy: a. 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; b. 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. | |
All Cause Mortality |
||
| SABR Boost Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/16 (43.8%) | |
Serious Adverse Events |
||
| SABR Boost Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/16 (6.3%) | |
| Gastrointestinal disorders | ||
| Death | 1/16 (6.3%) | 1 |
| Diarrhea | 1/16 (6.3%) | 16 |
Other (Not Including Serious) Adverse Events |
||
| SABR Boost Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/16 (6.3%) | |
| Gastrointestinal disorders | ||
| Rectal Fistula | 1/16 (6.3%) | |
| Rectal Bleeding | 1/16 (6.3%) | |
| Diarrhea | 1/16 (6.3%) | |
| Rectal Proctitis | 1/16 (6.3%) | |
| Rectal Ulcer | 1/16 (6.3%) | |
| Dysuria | 1/16 (6.3%) | |
| Rectal pain | 1/16 (6.3%) | |
| Reproductive system and breast disorders | ||
| Vaginal Bleeding | 1/16 (6.3%) | |
| Vaginal Pain | 1/16 (6.3%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr.Kevin Albuquerque |
|---|---|
| Organization | UT Southwestern/Simmons Cancer Center-Dallas |
| Phone | 2146458499 |
| Kevin.Albuquerque@UTSouthwestern.edu |
- STU 082013-064