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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01494012
First received: December 13, 2011
Last updated: October 8, 2013
Last verified: October 2013

December 13, 2011
October 8, 2013
April 2012
September 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01494012 on ClinicalTrials.gov Archive Site
  • 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 ]
  • CA-125 [ Time Frame: At baseline; 6 weeks; and 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • FOSI [ 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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    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
Experimental: Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Radiation: stereotactic body radiation therapy
  • Procedure: positron emission tomography
  • Procedure: computed tomography
  • Other: questionnaire administration
  • Radiation: fludeoxyglucose F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01494012
GYNOVA0021, NCI-2011-03652, SU-12072011-8791, 22550
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Elizabeth Kidd Stanford University
Stanford University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP