Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

April 26, 2017 updated by: Elizabeth Kidd, Stanford University

A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate response of platinum-resistant ovarian cancer to stereotactic body radiation therapy (SBRT) using fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) 3 months after therapy.

II. Determine the rate of grade 3 or greater non-hematologic acute toxicity from SBRT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

SECONDARY OBJECTIVES:

I. Evaluate response to SBRT using cancer antigen-125 (CA-125) and symptom assessment using Functional Assessment of Cancer Therapy (FACT)-Ovarian Symptom Index (FOSI).

II. Determine the rate of late and non-grade 3 acute toxicity using CTCAE version 4.0.

III. Evaluate local control, progression-free survival, and overall survival following SBRT.

OUTLINE:

Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6 weeks, 3, 6, 9, and 12 months, and then every 6 months for 4 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have persistent, metastatic, or recurrent platinum resistant or refractory ovarian or primary peritoneal cancer.
  • No restriction on previous treatment regimens, but patients must be at least 2 weeks out from last chemotherapy or investigational agent.
  • Patients must be >= 18.
  • Patients must have a life expectancy of at least 6 months.
  • Patients must have KPS >= 60.

  • Patients must have acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy):

    • leukocytes >=3,000/uL
    • absolute neutrophil count >=1,500uL
    • platelets >=100,000/uL
    • total bilirubin within 1.5X normal institutional limits
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients must be willing to undergo a pre- and post-treatment FDG-PET/CT.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients should not have received radiation overlapping with the proposed treatment field.
  • Patients cannot be receiving chemotherapy or other investigation agents from two weeks prior to radiation through undergoing their post-therapy FDG-PET/CT
  • Patients cannot be pregnant or nursing.
  • Patients cannot have disease >= 8cm or greater than 3 regions of disease.
  • Patients cannot have concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Other: questionnaire administration
Ancillary studies
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy
Procedure: positron emission tomography
Undergo FDG-PET/CT
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo FDG-PET/CT
Other Names:
  • tomography, computed
Drug: fludeoxyglucose F 18
Undergo FDG-PET/CT
Other Names:
  • 18FDG
  • FDG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumor response to SBRT as assessed by FDG-PET/CT
Time Frame: At 3 months
FDG-PET response based on interpretation by nuclear medicine physician with measurement of the maximal standard uptake value (SUV) and identification of new sites of disease. Percentage of decreased SUVmax between the pre- and post-treatment FDG-PET/CT, evaluating means, medians, range and standard deviations.
At 3 months
The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0
Time Frame: 4-6 weeks, and up to 3 months after treatment
Toxicity will be tabulated by type and grade.
4-6 weeks, and up to 3 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression-free survival
Time Frame: Up to 5 years
Up to 5 years
Overall survival
Time Frame: Up to 5 years
Up to 5 years
Measure CA-125 level
Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months
At baseline; 6 weeks; and 3, 6, and 12 months
FACT-Ovarian Symptom Index
Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months
At baseline; 6 weeks; and 3, 6, and 12 months
Late toxicity and non-grade 3 or greater acute toxicity following SBRT
Time Frame: At 6 weeks; 3, 6, 12, 18 and 24 months
At 6 weeks; 3, 6, 12, 18 and 24 months
Local control
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Kidd, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GYNOVA0021
  • NCI-2011-03652 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • SU-12072011-8791 (OTHER: Stanford University)
  • 22550 (OTHER: Stanford IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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