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


Condition: Cancer Patients Receiving Stereotactic Body RTX

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02170181

Sponsor: University of Texas Southwestern Medical Center

Phase:

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: All

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. 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.

View trial on ClinicalTrials.gov