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

NCT ID: NCT01494012

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (SBRT)

Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo SBRT

positron emission tomography

Intervention Type: PROCEDURE

Undergo FDG-PET/CT

computed tomography

Intervention Type: PROCEDURE

Undergo FDG-PET/CT

questionnaire administration

Intervention Type: OTHER

Ancillary studies

fludeoxyglucose F 18

Intervention Type: DRUG

Undergo FDG-PET/CT

Interventions

stereotactic body radiation therapy

Undergo SBRT

Intervention Type: RADIATION

positron emission tomography

Undergo FDG-PET/CT

Intervention Type: PROCEDURE

computed tomography

Undergo FDG-PET/CT

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

fludeoxyglucose F 18

Undergo FDG-PET/CT

Intervention Type: DRUG

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy; FDG-PET; PET; PET scan; tomography, emission computed; tomography, computed; 18FDG; FDG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Kidd

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Kidd

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

NCI-2011-03652

Identifier Type: REGISTRY

Identifier Source: secondary_id

SU-12072011-8791

Identifier Type: OTHER

Identifier Source: secondary_id

22550

Identifier Type: OTHER

Identifier Source: secondary_id

GYNOVA0021

Identifier Type: -

Identifier Source: org_study_id