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The study was prematurely closed due to unacceptable toxicity.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABR Boost Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABR Boost Therapy | Radiation |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Albuquerque, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SABR Boost Therapy | SABR Boost Therapy for cervix cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Image Guided Hypfractioned Radiation Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | 95% Confidence Interval | daya | 2 years |
|
|
The AE's were collected up to 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SABR Boost Therapy | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal Fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Study was not completed .the total number of accrual was not met
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Kevin Albuquerque | UT Southwestern/Simmons Cancer Center-Dallas | 2146458499 | Kevin.Albuquerque@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2017 | May 31, 2019 | Prot_SAP_000.pdf |
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|
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 7 |
| 16 |
| 1 |
| 16 |
| 1 |
| 16 |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | 1 patient developed grade 2 rectal bleeding. Of the grade 3 toxicities, 1 patient had grade 3 diarrhea consisting of greater than 8 stools over baseline per day which occurred 32 days after treatment and lasted two days. |
|
| Rectal Bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vaginal Bleeding | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal Ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysuria | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal Pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
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