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

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ClinicalTrials.gov Identifier: NCT01494012
Recruitment Status : Terminated (low accrual)
First Posted : December 16, 2011
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Elizabeth Kidd, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Malignant Tumor of Peritoneum Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor Radiation: stereotactic body radiation therapy Procedure: positron emission tomography Procedure: computed tomography Other: questionnaire administration Drug: fludeoxyglucose F 18 Phase 1

Detailed Description:


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.


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
Study Start Date : April 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
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
  • PET scan
  • tomography, emission computed

Procedure: computed tomography
Undergo FDG-PET/CT
Other Name: tomography, computed

Other: questionnaire administration
Ancillary studies

Drug: fludeoxyglucose F 18
Undergo FDG-PET/CT
Other Names:
  • 18FDG
  • FDG

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Measure CA-125 level [ Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months ]
  2. FACT-Ovarian Symptom Index [ Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months ]
  3. Late toxicity and non-grade 3 or greater acute toxicity following SBRT [ Time Frame: At 6 weeks; 3, 6, 12, 18 and 24 months ]
  4. Local control [ Time Frame: Up to 5 years ]
  5. Progression-free survival [ Time Frame: Up to 5 years ]
  6. Overall survival [ Time Frame: Up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494012

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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Elizabeth Kidd Stanford University
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Responsible Party: Elizabeth Kidd, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01494012    
Other Study ID Numbers: GYNOVA0021
NCI-2011-03652 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SU-12072011-8791 ( Other Identifier: Stanford University )
22550 ( Other Identifier: Stanford IRB )
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Germ Cell and Embryonal
Peritoneal Neoplasms
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action