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Radiation Therapy
Radiation Therapy for Cancer
Phase 1
Waitlist Available
Led By Christine Fisher, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the completion of sbrt treatment, throughout followup, or death, whichever comes first, up to one year.
Awards & highlights
Study Summary
This trial is testing a new radiation therapy for ovarian or uterine cancer that has come back. The new therapy sends x-rays directly to the tumor using smaller doses over several days.
Who is the study for?
This trial is for women over 18 with recurrent ovarian or uterine cancer, specifically serous cystadenocarcinoma. Participants must have a good performance status (ECOG 0 or 1), up to three sites of active disease in the abdomen/pelvis, and can't start treatment within a week of systemic therapy. Those with other recent cancers, active collagen diseases like lupus, inflammatory bowel conditions, or pregnancy are excluded.Check my eligibility
What is being tested?
The study tests stereotactic body radiation therapy (SBRT) to find the safest dose that's also effective for treating recurrent ovarian/uterine cancer. SBRT targets tumors precisely with x-rays over several days to minimize damage to healthy tissue. Patients may also undergo questionnaires and biomarker analysis.See study design
What are the potential side effects?
Potential side effects include localized skin reactions, fatigue due to radiation exposure, gastrointestinal symptoms such as nausea or diarrhea if nearby organs are affected by the radiation beams, and possible mild blood count changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after the completion of sbrt treatment, throughout followup, or death, whichever comes first, up to one year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the completion of sbrt treatment, throughout followup, or death, whichever comes first, up to one year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Acute Toxicities
Chemotherapy-Free Interval
Functional Imaging
+6 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Anorexia
21%
Chest pain
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Dehydration
7%
Blurred vision
7%
Sinusitis
7%
Otitis externa
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Hypertension
7%
Creatinine increased
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT)Experimental Treatment4 Interventions
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,568 Total Patients Enrolled
2 Trials studying Ovarian Cancer
16,743 Patients Enrolled for Ovarian Cancer
Christine Fisher, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer in more than one part of my body that may need treatment besides the study.I can start SBRT 7 days after my last systemic therapy, and resume systemic therapy 7 days after SBRT.I can't have IV contrast but my tumor can be seen clearly without it.I have had another type of cancer besides skin cancer within the last 5 years.I am a woman older than 18.I have or had collagen vascular disease but no active symptoms now.I have up to 3 active cancer sites, with one in my abdomen or pelvis (not liver) under 5 cm.I am fully active or can carry out light work.I am not pregnant or have been tested for pregnancy.I have been diagnosed with ovarian, fallopian tube, peritoneal, or uterine cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor seeking new participants?
"Unfortunately, this is not an active trial at the moment. It was first posted on October 27th 2017 and most recently updated on May 24th 2022. However, there are 3298 alternative studies actively searching for volunteers currently."
Answered by AI
Are there any significant risks associated with Stereotactic Body Radiation Therapy?
"Due to the limited clinical evidence on Stereotactic Body Radiation Therapy, our experts at Power rated its safety as a 1. This is reflective of the Phase 1 status of this trial and lack of supporting data around efficacy and safety."
Answered by AI
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