Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer (NCT NCT02045433)

NCT ID: NCT02045433

Last Updated: 2020-08-21

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2020-08-21

Participant Flow

Participant milestones

Measure	SABR Boost Therapy SABR Boost Therapy for cervix cancer
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	SABR Boost Therapy SABR Boost Therapy for cervix cancer
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer

Baseline characteristics by cohort

Measure	Image Guided Hypfractioned Radiation Treatment n=16 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex/Gender, Customized Female participants	16 Participants n=5 Participants
Sex/Gender, Customized male participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SABR Boost Therapy n=16 Participants SABR Boost Therapy
Time Taken to Induce Primary Tumor Control	55 daya Interval 55.0 to 77.0

Adverse Events

SABR Boost Therapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 7 deaths

Serious adverse events

Measure	SABR Boost Therapy n=16 participants at risk 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.
Gastrointestinal disorders Death	6.2% 1/16 • Number of events 1 • The AE's were collected up to 90 days
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Number of events 16 • The AE's were collected up to 90 days

Other adverse events

Measure	SABR Boost Therapy n=16 participants at risk 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.
Gastrointestinal disorders Rectal Fistula	6.2% 1/16 • The AE's were collected up to 90 days
Gastrointestinal disorders Rectal Bleeding	6.2% 1/16 • The AE's were collected up to 90 days
Gastrointestinal disorders Diarrhea	6.2% 1/16 • The AE's were collected up to 90 days
Reproductive system and breast disorders Vaginal Bleeding	6.2% 1/16 • The AE's were collected up to 90 days
Gastrointestinal disorders Rectal Proctitis	6.2% 1/16 • The AE's were collected up to 90 days
Gastrointestinal disorders Rectal Ulcer	6.2% 1/16 • The AE's were collected up to 90 days
Gastrointestinal disorders Dysuria	6.2% 1/16 • The AE's were collected up to 90 days
Gastrointestinal disorders Rectal pain	6.2% 1/16 • The AE's were collected up to 90 days
Reproductive system and breast disorders Vaginal Pain	6.2% 1/16 • The AE's were collected up to 90 days

Additional Information

Dr.Kevin Albuquerque

UT Southwestern/Simmons Cancer Center-Dallas

Phone: 2146458499

Email: Kevin.Albuquerque@UTSouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place