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Recurrent Ovarian Epithelial CancerPhase 1NCT01494012

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

A Phase 1 study testing stereotactic body radiation therapy, positron emission tomography and computed tomography in people with Recurrent Ovarian Epithelial Cancer and Recurrent Ovarian Germ Cell Tumor, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
stereotactic body radiation therapy, positron emission tomography and computed tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Apr 2012to Sep 2012
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

  • 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):
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
stereotactic body radiation therapy, positron emission tomography, computed tomography, questionnaire administration, fludeoxyglucose F 18
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • stereotactic body radiation therapyRadiation

    Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy

    Undergo SBRT

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Undergo FDG-PET/CT

  • computed tomographyProcedure or surgery

    Also called tomography, computed

    Undergo FDG-PET/CT

  • questionnaire administrationOther

    Ancillary studies

  • fludeoxyglucose F 18Drug

    Also called 18FDG, FDG

    Undergo FDG-PET/CT

Study groups in NCT01494012
Study groupRoleWhat they receive
Treatment (SBRT)ExperimentalPatients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: stereotactic body radiation therapy; Procedure: positron emission tomography; Procedure: computed tomography; Other: questionnaire administration; Drug: fludeoxyglucose F 18

What is being measured

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

  1. Tumor response to SBRT as assessed by FDG-PET/CT

    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.

    Measured: At 3 months

  2. The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0

    Toxicity will be tabulated by type and grade.

    Measured: 4-6 weeks, and up to 3 months after treatment

Secondary outcomes (6)

  1. Measure CA-125 level

    Measured: At baseline; 6 weeks; and 3, 6, and 12 months

  2. FACT-Ovarian Symptom Index

    Measured: At baseline; 6 weeks; and 3, 6, and 12 months

  3. Late toxicity and non-grade 3 or greater acute toxicity following SBRT

    Measured: At 6 weeks; 3, 6, 12, 18 and 24 months

  4. Local control

    Measured: Up to 5 years

  5. Progression-free survival

    Measured: Up to 5 years

  6. Overall survival

    Measured: Up to 5 years

Timeline

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

  1. First posted16 Dec 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2012
  4. Study completionSep 2012

Why it stopped: low accrual

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01494012
Sponsor's protocol ID
GYNOVA0021
Other IDs
NCI-2011-03652, SU-12072011-8791, 22550
Status last verified
Apr 2017
First submitted
13 Dec 2011
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing stereotactic body radiation therapy, positron emission tomography and computed tomography in people with Recurrent Ovarian Epithelial Cancer and Recurrent Ovarian Germ Cell Tumor, run by Stanford University 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 15 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Apr 2017. 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 was stopped early (reason given: low accrual). Results are not available in the source record.

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?

Tumor response to SBRT as assessed by FDG-PET/CT (time frame: At 3 months). The study lists 2 primary outcomes in all. 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 NCT01494012.

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 28 Apr 2017.

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