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

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01494012
First received: December 13, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Malignant Tumor of Peritoneum
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
 Radiation: stereotactic body radiation therapy
Procedure: positron emission tomography
Procedure: computed tomography
Other: questionnaire administration
Radiation: fludeoxyglucose F 18
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Tumor response to SBRT as assessed by FDG-PET/CT [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4-6 weeks, and up to 3 months after treatment ] [ Designated as safety issue: Yes ]
    Toxicity will be tabulated by type and grade.


Secondary Outcome Measures:
  • Measure CA-125 level [ Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • FACT-Ovarian Symptom Index [ Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Late toxicity and non-grade 3 or greater acute toxicity following SBRT [ Time Frame: At 6 weeks; 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • Local control [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
 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:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo FDG-PET/CT
Other Name: tomography, computed
Other: questionnaire administration
Ancillary studies
Radiation: fludeoxyglucose F 18
Undergo FDG-PET/CT
Other Names:
  • 18FDG
  • FDG

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494012

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Elizabeth A. Kidd     650-725-2174     ekidd@stanford.edu    
Principal Investigator: Elizabeth A. Kidd            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Elizabeth Kidd Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01494012     History of Changes
Other Study ID Numbers: GYNOVA0021, NCI-2011-03652, SU-12072011-8791, 22550
Study First Received: December 13, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 19, 2013