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

Primary Purpose

Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Malignant Tumor of Peritoneum

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

stereotactic body radiation therapy

positron emission tomography

computed tomography

questionnaire administration

fludeoxyglucose F 18

About this trial

This is an interventional treatment trial for Recurrent Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Measure CA-125 level

FACT-Ovarian Symptom Index

Late toxicity and non-grade 3 or greater acute toxicity following SBRT

Local control

Progression-free survival

Overall survival

Full Information

NCT ID

NCT01494012

First Posted

December 13, 2011

Last Updated

April 26, 2017

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01494012

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (SBRT)

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiation therapy

Other Intervention Name(s)

SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Intervention Description

Undergo SBRT

Intervention Type

Procedure

Intervention Name(s)

positron emission tomography

Other Intervention Name(s)

FDG-PET, PET, PET scan, tomography, emission computed

Intervention Description

Undergo FDG-PET/CT

Intervention Type

Procedure

Intervention Name(s)

computed tomography

Other Intervention Name(s)

tomography, computed

Intervention Description

Undergo FDG-PET/CT

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Drug

Intervention Name(s)

fludeoxyglucose F 18

Other Intervention Name(s)

18FDG, FDG

Intervention Description

Undergo FDG-PET/CT

Primary Outcome Measure Information:

Title

Tumor response to SBRT as assessed by FDG-PET/CT

Description

Time Frame

At 3 months

Title

The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0

Description

Toxicity will be tabulated by type and grade.

Time Frame

4-6 weeks, and up to 3 months after treatment

Secondary Outcome Measure Information:

Title

Measure CA-125 level

Time Frame

At baseline; 6 weeks; and 3, 6, and 12 months

Title

FACT-Ovarian Symptom Index

Time Frame

At baseline; 6 weeks; and 3, 6, and 12 months

Title

Late toxicity and non-grade 3 or greater acute toxicity following SBRT

Time Frame

At 6 weeks; 3, 6, 12, 18 and 24 months

Title

Local control

Time Frame

Up to 5 years

Title

Progression-free survival

Time Frame

Up to 5 years

Title

Overall survival

Time Frame

Up to 5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Kidd

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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