NCT01494012

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

December 13, 2011

Last Update Submit

April 26, 2017

Conditions

Recurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorMalignant Tumor of PeritoneumStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell Tumor

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

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

Radiation: stereotactic body radiation therapyProcedure: positron emission tomographyProcedure: computed tomographyOther: questionnaire administrationDrug: fludeoxyglucose F 18

Interventions

stereotactic body radiation therapyRADIATION

Undergo SBRT

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Treatment (SBRT)
positron emission tomographyPROCEDURE

Undergo FDG-PET/CT

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Treatment (SBRT)
computed tomographyPROCEDURE

Undergo FDG-PET/CT

Also known as: tomography, computed
Treatment (SBRT)
questionnaire administrationOTHER

Ancillary studies

Treatment (SBRT)
fludeoxyglucose F 18DRUG

Undergo FDG-PET/CT

Also known as: 18FDG, FDG
Treatment (SBRT)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

RadiosurgeryMagnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Elizabeth Kidd

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiation Oncology

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 16, 2011

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

US(1)