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Completed

NCT Number: NCT02582931

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI-guided SBRT

Device

Other names: MRI-guided stereotactic body radiation therapy

EORTC QLQ-C30 Questionnaire

Behavioral

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

Behavioral

28 questions having answers that range from 1 (not at all) to 4 (very much)

Primary outcomes

  1. 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

    Time frame: Completion of all enrolled patients (up to 2 years)

Secondary outcomes

  1. Safety as measured by acute toxicities

    Time frame: Up to 90 days post completion of treatment

    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.

  2. Safety as measured by late toxicities

    Time frame: 91 days to 6 months post completion of treatment

    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.

  3. Response rate

    Time frame: 3 months post treatment

    -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].

  4. In-field control rate

    Time frame: 6 months post treatment

  5. Local control rate

    Time frame: 3 months post treatment

  6. Regional control rate

    Time frame: 3 months post treatment

  7. Distant control rate

    Time frame: 3 months post treatment

  8. Progression-free survival (PFS) rate

    Time frame: 6 months post treatment

    -PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

  9. Disease-free survival (DFS) rate

    Time frame: 6 months post treatment

    -The length of time that a patient survives without any signs or symptoms of their cancer

  10. Overall survival (OS) rate

    Time frame: 6 months post treatment

  11. Patient-reported health-related quality of life (HRQOL)

    Time frame: 6 months post treatment

    • 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)
  12. CA-125 response levels

    Time frame: 6 months post treatment

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2015
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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