NCT01494012

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Malignant Tumor of Peritoneum
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy	Undergo SBRT
PROCEDURE	positron emission tomography	Undergo FDG-PET/CT
PROCEDURE	computed tomography	Undergo FDG-PET/CT
OTHER	questionnaire administration	Ancillary studies
DRUG	fludeoxyglucose F 18	Undergo FDG-PET/CT

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-12-16
• Last updated: 2017-04-28

Locations

1 site across 1 country: United States