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

Recurrent Ovarian Epithelial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01494012
• Other study ID #: GYNOVA0021
• Secondary ID: NCI-2011-03652SU
• Status: Terminated
• Phase: Phase 1
• First received: December 13, 2011
• Last updated: April 26, 2017
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: April 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Germinoma
• Malignant Tumor of Peritoneum
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT

Procedure:
• positron emission tomography
Undergo FDG-PET/CT
• computed tomography
Undergo FDG-PET/CT

Other:
• questionnaire administration
Ancillary studies

Drug:
• fludeoxyglucose F 18
Undergo FDG-PET/CT

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Measure CA-125 level		At baseline; 6 weeks; and 3, 6, and 12 months
Secondary	FACT-Ovarian Symptom Index		At baseline; 6 weeks; and 3, 6, and 12 months
Secondary	Late toxicity and non-grade 3 or greater acute toxicity following SBRT		At 6 weeks; 3, 6, 12, 18 and 24 months
Secondary	Local control		Up to 5 years
Secondary	Progression-free survival		Up to 5 years
Secondary	Overall survival		Up to 5 years