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

Phase 1
18 Years
Open (Enrolling)
Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Malignant Tumor of Peritoneum, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor

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Trial Information

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


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.

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

Exclusion Criteria:

- Patients should not have received radiation overlapping with the proposed treatment

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

At 3 months

Safety Issue:


Principal Investigator

Elizabeth Kidd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

December 2014

Related Keywords:

  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Malignant Tumor of Peritoneum
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Germinoma
  • Neoplasms, Glandular and Epithelial



Stanford UniversityStanford, California  94305