Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325634
Recruitment Status : Active, not recruiting
First Posted : October 30, 2017
Last Update Posted : November 3, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with ovarian or uterine cancer that has come back. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
Recurrent Endometrial Serous Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy Phase 1

Detailed Description:
This is a phase I study with a primary objective to determine maximum tolerated dose (MTD) of 3 fraction stereotactic body radiation therapy (SBRT) for abdominopelvic recurrences of ovarian cancer (OC) and uterine papillary serous carcinoma (UPSC). This is a dose escalation study that employs a 3+3 design to determine the MTD. Patients are then monitored closely to determine side effects and adverse events, as well as success rates and tumor response to the radiation therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : November 21, 2021
Estimated Study Completion Date : November 23, 2023


Arm Intervention/treatment
Experimental: Treatment (SBRT)
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: After the completion of SBRT treatment through 3 months of followup. ]
    This will be accomplished using the standard 3+3 dose escalation design. Dose Limiting Toxicities (DLTs) will be determined through the NCI CTCAE version 4.03.


Secondary Outcome Measures :
  1. One Year Local Control [ Time Frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year. ]
    Local Control will be defined as Stable Disease (SD), Partial Response (PR) or Complete Repsonse (CR) according to RECIST 1.1 criteria. Assessed using Kaplan Meier survival curves.

  2. Progression Free Survival [ Time Frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year. ]
    The amount of time a patient survives without worsening of disease, according to RECIST 1.1 criteria. Assessed using Kaplan Meier survival curves.

  3. Overall Survival [ Time Frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year. ]
    The amount of time a patient survives, with or without progression of disease. Assessed using Kaplan Meier survival curves.

  4. Chemotherapy-Free Interval [ Time Frame: After the completion of SBRT treatment throughout followup to the re-initiation of chemotherapy, up to one year. ]
    The amount of time a patient survives without having to undergo re-initiation of chemotherapy. Assessed using Kaplan Meier survival curves.

  5. Acute Toxicities [ Time Frame: During SBRT treatment, throughout followup, or death, whichever comes first, up to 6 weeks post treatment. ]
    Acute toxicities will be assessed by the NCI CTCAE version 4.03.

  6. Late Toxicities [ Time Frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year. ]
    Delayed toxicities will be assessed by the NCI CTCAE version 4.03.

  7. Quality of Life Assessment through Survey [ Time Frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year. ]
    Quality of life will be assessed through the EORTC QLQ-C30 and OV28 questionnaires.

  8. Functional Imaging [ Time Frame: Prior to completion of SBRT, immediately after the completion of SBRT, and 6 weeks after the completion of SBRT. ]
    DCE-CT scans using the Siemens AS open scanner will be assessed according to RECIST 1.1 criteria.

  9. Profile of SBRT-Associated Immune Response [ Time Frame: Prior to completion of SBRT, 2 weeks after the completion of SBRT, and 6 weeks after the completion of SBRT. ]
    The Human Immune Monitoring Shared Resource will preform cytometry and cytokine arrays, as well as characterizing activation markers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients > 18 years of age.
  • ECOG 0 or 1.
  • Diagnosis of primary ovarian cancer of any histology (patients with diagnoses of fallopian tube and primary peritoneal cancer are also eligible), or primary uterine cancer of papillary serous histology.
  • Pathologic confirmation of eligible histology.
  • Three or fewer total sites of active disease (at least one site of active disease to be treated on study must be confined to the abdomen or pelvis excluding liver and must be < 5 cm in greatest dimension as determined by pre-screening cross-sectional imaging).
  • Additional site(s) of active disease (such as parenchymal liver and lung metastases, or supraclavicular nodal metastases), should be considered for treatment (off study) with radiation, surgery, or another form of local therapy, at the discretion of the study PI.
  • Systemic therapy is allowed but SBRT cannot begin until > or = 7 days after the last cycle of systemic therapy, and systemic therapy cannot be initiated or re-initiated until > or = 7 days after SBRT. There will be no limit on prior lines of systemic therapy.
  • Patients with contraindications to intravenous (IV) contrast administration are still eligible for this study if the tumor can be delineated clearly without IV contrast (at the discretion of the treating radiation oncologist) but will not participate in the functional imaging studies.

Exclusion Criteria:

  • Pregnant women. If patients are not status post bilateral salpingo-oopherectomy then pregnancy testing is required.
  • Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI.
  • Patients with inflammatory bowel disease and/or GI ulcers and/or GI fistulas are eligible but only at the discretion of the study PI after personalized review of their medical history and proximity of SBRT targets to gastrointestinal mucosa.
  • Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325634


Locations
Layout table for location information
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Christine Fisher, MD University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03325634    
Other Study ID Numbers: 17-1333.cc
NCI-2017-01888 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
17-1333 ( Other Identifier: University of Colorado Hospital )
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous