AzTrials
AzTrials

Cancer of OvaryPhase 1NCT02582931

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

A Phase 1 study testing MRI-guided SBRT, EORTC QLQ-C30 Questionnaire and EORTC QLQ-OV28 Questionnaire in people with Cancer of Ovary and Cancer of the Ovary, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
MRI-guided SBRT, EORTC QLQ-C30 Questionnaire and EORTC QLQ-OV28 Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
2 Dec 2015to 13 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Pilot Study of 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.

Being tested
MRI-guided SBRT, EORTC QLQ-C30 Questionnaire, EORTC QLQ-OV28 Questionnaire
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI-guided SBRTDevice

    Also called MRI-guided stereotactic body radiation therapy

  • EORTC QLQ-C30 QuestionnaireBehavioural

    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 QuestionnaireBehavioural

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

Study groups in NCT02582931
Study groupRoleWhat they receive
Arm 1: MRI-guided SBRTExperimental* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments. * Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV. * All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
Receives: Device: MRI-guided SBRT; Behavioral: EORTC QLQ-C30 Questionnaire; Behavioral: EORTC QLQ-OV28 Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (12)

  1. 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.

    Measured: Up to 90 days post completion of treatment

  2. 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.

    Measured: 91 days to 6 months post completion of treatment

  3. 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].

    Measured: 3 months post treatment

  4. In-field control rate

    Measured: 6 months post treatment

  5. Local control rate

    Measured: 3 months post treatment

  6. Regional control rate

    Measured: 3 months post treatment

  7. Distant control rate

    Measured: 3 months post treatment

  8. 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.

    Measured: 6 months post treatment

  9. Disease-free survival (DFS) rate

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

    Measured: 6 months post treatment

  10. Overall survival (OS) rate

    Measured: 6 months post treatment

  11. 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)

    Measured: 6 months post treatment

  12. CA-125 response levels

    Measured: 6 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2015 (estimated)
  2. Study start2 Dec 2015
  3. Primary completion14 May 2018
  4. Study completion13 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02582931
Sponsor's protocol ID
201510101
Status last verified
Jan 2019
First submitted
20 Oct 2015
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRI-guided SBRT, EORTC QLQ-C30 Questionnaire and EORTC QLQ-OV28 Questionnaire in people with Cancer of Ovary and Cancer of the Ovary, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02582931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in