CompletedNot Applicable

Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation

United States149 participantsStarted 2014-05-28

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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.
✓.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:

What they're measuring

patterns of care

Timeframe: 5 years

Trial details

NCT IDNCT02170181

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08

View on ClinicalTrials.gov More Cancer Patients Receiving Stereotactic Body RTX trials