Clinical trial NCT03977311: MR-Guided High-Intensity Focused Ultrasound in Conjunction With Radiation Therapy for the Treatment of Locally Advanced Cervical Cancer
Official title: A Pilot Study Evaluating the Safety and Feasibility of MR-Guided High-Intensity Focused Ultrasound in Conjunction With Radiation Therapy for the Treatment of Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, safety and feasibility of MR-guided HIFU hyperthermia application will be assessed in patients diagnosed with locally advanced cervical cancer. This site has reasonable soft tissue pathways and depths for the ultrasound to access with limited osseous or air interference. Additionally, of cervical cancer patients who develop recurrence following standard treatment, approximately 1/3 will recur locally and an additional 1/3 recur both locally and distantly. Risk of local failure increases with higher FIGO staging. Therefore, patients with locally advanced cervical cancer stand to benefit from adjuvant hyperthermia to potentially increase local disease control outcomes. While MR-HIFU may conceivably increase risk for local complications such as fistula formation, these risks are felt to be acceptable given the potential morbidity of local disease failure, which often can only be addressed curatively by pelvic exenteration. In this study, testing will be performed within tumor volumes involving the cervix uteri. Heating will be to the therapeutic level of 41-42°C for 30-60 minutes, a commonly utilized therapeutic target. This session duration will be achieved in either a single session either before or after the radiotherapy fraction or in an optional two sessions of 15-30 minutes both before and after the radiotherapy fraction, for a total time of 30-60 minutes one day per week. This study will help to elucidate the feasibility of achieving and maintaining therapeutic hyperthermia within an entire tumor volume over the goal period of time of 30-60 minutes.

The investigators anticipate that successful completion of this study will lead to further clinical trials investigating the treatment efficacy in terms of added local control compared to traditional, standard-of-care radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed histologically or cytologically confirmed locally advanced cervical cancer, FIGO Stage IB2 to IVA
* Measurable disease per RECIST 1.1.
* At least 18 years of age.
* ECOG performance status ≤ 3 (Karnofsky ≥ 60%)
* Planned treatment includes radiation therapy.
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Currently receiving any investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Pacemaker or other implantable device subject to radiofrequency interference in the ultrasound field.
* Claustrophobia or other contraindications for MRI.

Primary outcomes:
measure: Feasibility of MR-HIFU hyperthermia: number of participants who achieve a temperature at or above 41 degrees Celsius
timeFrame: Completion of all participants with their radiation treatment (estimated to be 38 months)
measure: Number of device/treatment related adverse events recorded by frequency and severity
timeFrame: Through 12 months following completion of treatment (estimated to be 14 months)
Secondary outcomes:
measure: Local control rate
timeFrame: Through 12 months after completion of treatment (estimated to be 14 months)
measure: Comparison of Quality of life as measured by EORTC-QLQ-C30
timeFrame: Pre-treatment, 3 months after completion of radiation, and 6 months after completion of radiation
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Imran Zoberi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: