A Phase I Dose-Escalation Study of Stereotactic Radiosurgery for Brain Metastasis Without Whole Brain Radiation

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor.

• Radiographic evidence by MRI (or by CT scan with CT contrast if ineligible or intolerant of MRI) of brain metastasis. (If patient is unable to tolerate MRI contrast, an MRI without contrast is acceptable if lesions are visible)

• All brain metastases must be outside the brain stem (midbrain, pons and medulla).

• Patient must have 10 or less brain metastases.

• The maximum diameter of any lesion must be less than or equal to 3.0 cm.

• Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that:

‣ Radiation was not to the brain.

⁃ Surgery to the brain was \> 7 days prior to SRS and there remains at least one additional brain metastasis that can be targeted with SRS

• Age ≥ 18 years.

• ECOG Performance Score of 2 or better/Karnofsky Performance Status score of 50-60 or better.

• All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, 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).

⁃ Ability to understand and the willingness to sign a written informed consent.

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Jonathan VanPelt, MHA
Jonathan.VanPelt@UTSouthwestern.edu
214-645-5360
Backup
Sarah Hardee, MS
sarah.hardee@UTSouthwestern.edu
214-645-8525
Time Frame
Start Date: 2015-12-18
Estimated Completion Date: 2026-12
Participants
Target number of participants: 135
Treatments
Experimental: Stereotactic Radiosurgery
Radiation, Stereotactic Radiosurgery Dose-Escalation
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov