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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582931
• Other study ID #: 201510101
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2015
• Est. completion date: December 13, 2018

Study information

• Verified date: January 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 13, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.

• Deemed medically fit for stereotactic body radiation therapy by the treating physician.

• At least 18 years old.

• Karnofsky Performance Status = 70

• Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).

• Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).

Exclusion Criteria:

• Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT

• Current central nervous systemic disease.

• Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).

• Actively receiving any investigational agents.

• Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.

• Medical contraindication to undergoing MR imaging.

Related Conditions & MeSH terms

• Cancer of Ovary
• Cancer of the Ovary
• Neoplasms
• Neoplasms, Glandular and Epithelial
• Neoplasms, Ovarian
• Ovarian Cancer
• Ovarian Neoplasms
• Ovary Cancer
• Ovary Neoplasms

Intervention

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)
• EORTC QLQ-OV28 Questionnaire
28 questions having answers that range from 1 (not at all) to 4 (very much)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of providing online, adaptive MRI-guided and gated SBRT as measured by the ability to deliver a full course of MRI-guided SBRT in at least 80% of eligible patients who have completed simulation and planning		Completion of all enrolled patients (up to 2 years)
Secondary	Safety as measured by acute toxicities	the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.	Up to 90 days post completion of treatment
Secondary	Safety as measured by late toxicities	the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.	91 days to 6 months post completion of treatment
Secondary	Response rate	-Response will be measured using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].	3 months post treatment
Secondary	In-field control rate		6 months post treatment
Secondary	Local control rate		3 months post treatment
Secondary	Regional control rate		3 months post treatment
Secondary	Distant control rate		3 months post treatment
Secondary	Progression-free survival (PFS) rate	-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.	6 months post treatment
Secondary	Disease-free survival (DFS) rate	-The length of time that a patient survives without any signs or symptoms of their cancer	6 months post treatment
Secondary	Overall survival (OS) rate		6 months post treatment
Secondary	Patient-reported health-related quality of life (HRQOL)	HRQOL will be measured using the EORTC QLQ-C30 and QLQ-OV28 questionnaires.; European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 consists of 28 questions with answers that range from 1 (Not At All) to 4 (Very Much) and 2 questions that range from 1 (Very Poor) to 7 (Excellent); EORTC QLQ-OV28 consists of 28 questions ranging with answers from 1 (Not At All) to 4 (Very Much)	6 months post treatment
Secondary	CA-125 response levels		6 months post treatment

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine