NCT02582931

MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer

Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treatment machine. To best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. The prescription dose will be determined based on hard normal tissue constraints, and capped at 10Gy per fraction. Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.

Conditions

• Cancer of Ovary
• Cancer of the Ovary
• Neoplasms, Ovarian
• Ovarian Cancer
• Ovary Cancer
• Ovary Neoplasms

Interventions

Type	Name	Description
DEVICE	MRI-guided SBRT
BEHAVIORAL	EORTC QLQ-C30 Questionnaire	30 questions with 28 questions having answers that range from 1 (not at all) to 4 (very much) and the other 2 questions have answers that range from 1 (very poor) to 7 (excellent)
BEHAVIORAL	EORTC QLQ-OV28 Questionnaire	28 questions having answers that range from 1 (not at all) to 4 (very much)

Timeline

• Start date: 2015-12-02
• Primary completion: 2018-05-14
• Completion: 2018-12-13
• First posted: 2015-10-21
• Last updated: 2019-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study