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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Stanford University

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome:

  • 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.
  • The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0 [ Time Frame: During treatment, at 4-6 weeks, and up to 3 months after treatment ]
    Toxicity will be tabulated by type and grade.


Current Secondary Outcome:

  • Measure CA-125 level [ Time Frame: 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 ]
  • Late toxicity and non-grade 3 or greater acute toxicity following SBRT [ Time Frame: At 6 weeks; 3, 6, 12, 18 and 24 months ]
  • Local control [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • CA-125 [ Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months ]
  • FOSI [ Time Frame: 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 ]
  • Local control [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]


Information By: Stanford University

Dates:
Date Received: December 13, 2011
Date Started: April 2012
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017