Malignant Tumor of Peritoneum, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor
Conditions
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 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.
Interventions
RADIATIONstereotactic body radiation therapy
Undergo SBRT
PROCEDUREpositron emission tomography
Undergo FDG-PET/CT
PROCEDUREcomputed tomography
Undergo FDG-PET/CT
OTHERquestionnaire administration
Ancillary studies
DRUGfludeoxyglucose F 18
Undergo FDG-PET/CT
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response to SBRT as assessed by FDG-PET/CT | 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 | 4-6 weeks, and up to 3 months after treatment | Toxicity will be tabulated by type and grade. |
Secondary
| Measure | Time frame |
|---|---|
| Late toxicity and non-grade 3 or greater acute toxicity following SBRT | At 6 weeks; 3, 6, 12, 18 and 24 months |
| Local control | Up to 5 years |
| Measure CA-125 level | At baseline; 6 weeks; and 3, 6, and 12 months |
| Overall survival | Up to 5 years |
| Progression-free survival | Up to 5 years |
| FACT-Ovarian Symptom Index | At baseline; 6 weeks; and 3, 6, and 12 months |
Countries
United States
Outcome results
None listed