Locally Advanced Cervical Cancer
Conditions
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.
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.
Interventions
RADIATIONSABR Boost Therapy
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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Image Guided Hypfractioned Radiation Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 16 participants |
| Sex/Gender, Customized Female participants | 16 Participants |
| Sex/Gender, Customized male participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 16 |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
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
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SABR Boost Therapy | Time Taken to Induce Primary Tumor Control | 55 daya |