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

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.

Study Overview

• Status: Terminated
• Conditions: Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Malignant Tumor of Peritoneum
• Intervention / Treatment: Other: questionnaire administration; Radiation: stereotactic body radiation therapy; Procedure: positron emission tomography; Procedure: computed tomography; Drug: fludeoxyglucose F 18

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Treatment (SBRT); Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.

Other: questionnaire administration; Ancillary studies; Radiation: stereotactic body radiation therapy; Undergo SBRT; Other Names: SBRT; stereotactic radiation therapy; stereotactic radiotherapy; Procedure: positron emission tomography; Undergo FDG-PET/CT; Other Names: PET; FDG-PET; PET scan; tomography, emission computed; Procedure: computed tomography; Undergo FDG-PET/CT; Other Names: tomography, computed; Drug: fludeoxyglucose F 18; Undergo FDG-PET/CT; Other Names: 18FDG; FDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response to SBRT as assessed by FDG-PET/CT	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.	At 3 months
The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0	Toxicity will be tabulated by type and grade.	4-6 weeks, and up to 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	Up to 5 years
Overall survival	Up to 5 years
Measure CA-125 level	At baseline; 6 weeks; and 3, 6, and 12 months
FACT-Ovarian Symptom Index	At baseline; 6 weeks; and 3, 6, and 12 months
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Elizabeth Kidd, Stanford University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (ESTIMATE): December 16, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Abdominal Neoplasms; Neoplasms, Germ Cell and Embryonal; Recurrence; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Germinoma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: GYNOVA0021; NCI-2011-03652 (REGISTRY: CTRP (Clinical Trial Reporting Program)); SU-12072011-8791 (OTHER: Stanford University); 22550 (OTHER: Stanford IRB)