NCT02170181Completed
Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
This prospective protocol will enroll patients with pathologically confirmed solid malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for consolidation after systemic therapy, prior to systemic therapy for the purposes of debulking, or in the re-irradiation setting. Increasing use of SBRT off of clinical trials in patients with malignancies of all histologies is being utilized in these settings. However, individualized outcomes and characteristics of treatments are not prospectively followed and not well documented. By instituting a registry of patients receiving SBRT in these settings it will be possible to determine trends in patterns of care and outcomes for refinement and justification of this treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 149 (actual)
- First submitted
- 13 Jun 2014
- Start date
- 28 May 2014
- Primary completion date
- Aug 2025
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Prostate cancer, Kidney cancer, Bladder cancer, Lung cancer
- NCT number
- NCT02170181
What you commit to
- Study type: Observational
- Participants enrolled: 149
- From 28 May 2014 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1 Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- 2\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Other
- 3 Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Who the study is looking for
- Pathologically confirmed solid tumor malignancies which are locally advanced or metastatic.
- Able to safely receive intended protocol defined SBRT dose.
- For oligometastatic category, patients can have up to 6 sites of active extracranial disease amenable to SBRT with a maximum of 7 cm diameter
- Must have a CT C/A/P, or PET/CT scan within 12 weeks of enrollment.
- Age ≥ 18 years.
- Karnofsky performance status of 70 or higher, or ECOG \< 2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 7.1 a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Negative urine or serum pregnancy test for women of child-bearing potential
- Agreeable and willing to participate in expected protocol defined follow-up.
- Ability to understand and the willingness to sign a written informed consent.
- Registry participation does not exclude participation in clinical trials.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.