Registry for patients with oligometastatic cancer receiving SBRT
UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
This study is looking to see how well stereotactic body radiation therapy (SBRT) works for patients with certain types of cancer that have spread to a few places in the body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT02170181 on ClinicalTrials.gov |
What this trial studies
This prospective registry will enroll patients with confirmed solid tumors who are receiving stereotactic body radiation therapy (SBRT) for various treatment intents, including oligometastatic disease, consolidation after systemic therapy, debulking prior to chemotherapy, or re-irradiation. Patients will be categorized into treatment arms based on their specific condition and treatment goals. The aim is to document and analyze treatment outcomes and patterns of care to improve future applications of SBRT in oncology.
Who should consider this trial
Good fit: Ideal candidates include adults with pathologically confirmed solid tumors that are locally advanced or metastatic and who can safely receive SBRT.
Not a fit: Patients with non-solid tumors or those who cannot safely undergo SBRT may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of SBRT outcomes, leading to improved treatment strategies for cancer patients.
How similar studies have performed: Other studies utilizing SBRT for similar cancer conditions have shown promising outcomes, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathologically confirmed solid tumor malignancies which are locally advanced or metastatic. 2. Able to safely receive intended protocol defined SBRT dose. 3. For oligometastatic category, patients can have up to 6 sites of active extracranial disease amenable to SBRT with a maximum of 7 cm diameter 4. Must have a CT C/A/P, or PET/CT scan within 12 weeks of enrollment. 5. Age ≥ 18 years. 6. Karnofsky performance status of 70 or higher, or ECOG \< 2 7. 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). 8. Negative urine or serum pregnancy test for women of child-bearing potential 9. Agreeable and willing to participate in expected protocol defined follow-up. 10. Ability to understand and the willingness to sign a written informed consent. 11. Registry participation does not exclude participation in clinical trials. Exclusion Criteria: 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. 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.
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Asal Rahimi, MD — Utsw
- Study coordinator: Devin Holland
- Email: devin.holland@utsouthwestern.edu
- Phone: 2146458052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.