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

Phase 1

Terminated

• 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: Radiation: stereotactic body radiation therapy; Procedure: positron emission tomography; Procedure: computed tomography; Other: questionnaire administration; Drug: fludeoxyglucose F 18

• Registration Number: NCT01494012
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Study Start: 2012-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SBRT)	stereotactic body radiation therapy	Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Treatment (SBRT)	positron emission tomography	Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Treatment (SBRT)	computed tomography	Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Treatment (SBRT)	questionnaire administration	Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Treatment (SBRT)	fludeoxyglucose F 18	Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Progression-free survival	Up to 5 years

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States