Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemothera… (NCT02170181) | Clinical Trial Compass
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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
patterns of care
Timeframe: 5 years
Trial details
NCT IDNCT02170181
SponsorUniversity of Texas Southwestern Medical Center
.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: