RECRUITING

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

Conditions

Cancer Patients Receiving Stereotactic Body RTX SBRT prostate cancer lung cancer bladder cancer kidney cancer oligometastatic disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-05-28

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02170181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Devin Holland

CONTACT

2146458052

devin.holland@utsouthwestern.edu

Sarah Hardee, MS

CONTACT

2146458525

sarah.hardee@utsouthwestern.edu

Principal Investigator

Asal Rahimi, MD

PRINCIPAL_INVESTIGATOR

UTSW

Study Locations (Sites)

University of Texas Southwestern Medical Center

Dallas, Texas, 75239

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Asal Rahimi, MD, PRINCIPAL_INVESTIGATOR, UTSW

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-05-28

Study Completion Date2026-12

Study Record Updates

Study Start Date2014-05-28

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

SBRT
prostate cancer
lung cancer
bladder cancer
kidney cancer
oligometastatic disease

Additional Relevant MeSH Terms

Cancer Patients Receiving Stereotactic Body RTX