Clinical trial NCT03634267: MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer
Official title: MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Human Papillomavirus-Related Carcinoma
Human Papillomavirus-Related Cervical Carcinoma
Stage IB2 Cervical Cancer AJCC v8
Stage II Cervical Cancer AJCC v8
Stage II Vaginal Cancer AJCC v8
Stage IIA Cervical Cancer AJCC v8
Stage IIA Vaginal Cancer AJCC v8
Stage IIA1 Cervical Cancer AJCC v8
Stage IIA2 Cervical Cancer AJCC v8
Stage IIB Cervical Cancer AJCC v8
Stage IIB Vaginal Cancer AJCC v8
Stage III Cervical Cancer AJCC v8
Stage III Vaginal Cancer AJCC v8
Stage IIIA Cervical Cancer AJCC v8
Stage IIIB Cervical Cancer AJCC v8
Stage IVA Cervical Cancer AJCC v8
Stage IVA Vaginal Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-16
Enrollment: 26
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: This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Determine whether MRI guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (HR-CTV) D90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer.

SECONDARY OBJECTIVES:

I. Identify diffusion weighted MRI image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology.

II. Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry.

III. Identify potential correlates between clinical outcomes (survival, progression) and these data objectives (brachytherapy dosimetry/therapeutic ratio, diffusion-weighted MRI imaging features, tumor aspirate cytology findings).

IV. Define the financial costs and feasibility of an MRI-guided brachytherapy approach to determine the overall healthcare quality value (outcomes/cost) of this novel approach for application at other brachytherapy centers.

OUTLINE:

Participants undergo MRI scan during internal radiation therapy applicator placement.

Eligibility criteria: Inclusion Criteria:

* Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or
* Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy.

Exclusion Criteria:

* Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
* Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.

Primary outcomes:
measure: Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Diffusion weighted imaging (DWI) outcomes
timeFrame: Up to 4 years
measure: Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples
timeFrame: Up to 4 years
measure: Disease recurrence (local, regional, and distant)
timeFrame: Up to 4 years
measure: Overall survival
timeFrame: Up to 4 years
measure: Progression-free survival
timeFrame: Up to 4 years
measure: Incidence and severity of treatment-related toxicities
timeFrame: Up to 4 years
measure: Cost difference associated with the MRI-guided versus the standard process
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ann H Klopp
role: PRINCIPAL_INVESTIGATOR
References: