NCT03325634CompletedPhase 1
A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma
University of Colorado, Denver1 site in 1 country15 target enrollmentStarted: October 27, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients > 18 years of age.
- •ECOG 0 or
- •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.
Arms & Interventions
Treatment (SBRT)
Experimental
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Intervention: Stereotactic Body Radiation Therapy (Radiation)
Treatment (SBRT)
Experimental
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Intervention: Laboratory Biomarker Analysis (Other)
Treatment (SBRT)
Experimental
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Intervention: Quality-of-Life Assessment (Other)
Treatment (SBRT)
Experimental
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
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 Outcomes
- One Year Local Control(After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.)
- Overall Survival(After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.)
- Functional Imaging(Prior to completion of SBRT, immediately after the completion of SBRT, and 6 weeks after the completion of SBRT.)
- Profile of SBRT-Associated Immune Response(Prior to completion of SBRT, 2 weeks after the completion of SBRT, and 6 weeks after the completion of SBRT.)
- Chemotherapy-Free Interval(After the completion of SBRT treatment throughout followup to the re-initiation of chemotherapy, up to one year.)
- Quality of Life Assessment through Survey(After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.)
- Progression Free Survival(After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.)
- Acute Toxicities(During SBRT treatment, throughout followup, or death, whichever comes first, up to 6 weeks post treatment.)
- Late Toxicities(After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate CancerProstate AdenocarcinomaStage IV Non-Small Cell Lung CancerStage IV Breast CancerStage IV Prostate CancerMale Breast CarcinomaRecurrent Breast CarcinomaRecurrent Non-Small Cell Lung CarcinomaRecurrent Prostate CarcinomaNCT02206334NRG Oncology42
Completed
Not Applicable
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate CancerStage I Prostate AdenocarcinomaStage II Prostate AdenocarcinomaNCT02470897University of Wisconsin, Madison115
Terminated
Not Applicable
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck CancerRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage III Hypopharyngeal Squamous Cell CarcinomaStage III Laryngeal Squamous Cell CarcinomaStage III Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IVA Hypopharyngeal Squamous Cell CarcinomaStage IVB Laryngeal Squamous Cell CarcinomaStage IVB Nasopharyngeal Keratinizing Squamous Cell CarcinomaRecurrent Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage III Oral Cavity Squamous Cell CarcinomaStage IVA Oral Cavity Squamous Cell CarcinomaStage IVB Hypopharyngeal Squamous Cell CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaStage II Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IVC Laryngeal Squamous Cell CarcinomaStage IVC Oral Cavity Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaStage III Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage III Oropharyngeal Squamous Cell CarcinomaStage IVA Laryngeal Squamous Cell CarcinomaStage IVB Oral Cavity Squamous Cell CarcinomaStage IVC Hypopharyngeal Squamous Cell CarcinomaStage IVC Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IVA Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IVA Oropharyngeal Squamous Cell CarcinomaNCT02388932Case Comprehensive Cancer Center3
Terminated
Phase 1
Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorMalignant Tumor of PeritoneumStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorNCT01494012Stanford University1
Terminated
Not Applicable
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic or Recurrent Kidney CancerMetastatic Renal Cell CancerRecurrent Renal Cell CarcinomaStage IV Renal Cell CancerNCT02542202University of Chicago25