MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 1

Conditions: Stage IIB Vaginal Cancer AJCC v8; Stage IIIA Cervical Cancer AJCC v8; Stage III Cervical Cancer AJCC v8; Stage II Vaginal Cancer AJCC v8; Human Papillomavirus-Related Carcinoma; Stage IIA2 Cervical Cancer AJCC v8; Stage IVA Vaginal Cancer AJCC v8; Stage IIA Cervical Cancer AJCC v8; Stage IIIB Cervical Cancer AJCC v8; Stage IIA1 Cervical Cancer AJCC v8; Stage II Cervical Cancer AJCC v8; Stage IB2 Cervical Cancer AJCC v8; Stage IVA Cervical Cancer AJCC v8; Stage IIB Cervical Cancer AJCC v8; Stage III Vaginal Cancer AJCC v8; Stage IIA Vaginal Cancer AJCC v8; Human Papillomavirus-Related Cervical Carcinoma

Treatments: Radiation: Internal Radiation Therapy; Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03634267

P30CA016672 (U.S. NIH Grant/Contract)

2017-0823 (Other Identifier)

NCI-2018-01569 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Treatment (MRI, internal radiation therapy)

Experimental group

Description:

Participants undergo MRI scan during internal radiation therapy applicator placement.

Treatment:

Procedure: Magnetic Resonance Imaging

Radiation: Internal Radiation Therapy