NCT02170181Befejeződött
Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
UTSW SBRT Prospective Clinical Registry for Oligometastic Disease, Consolidation Therapy, Debulking Prior to Chemotherapy, or Re-Irradiation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 17.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 149 (tényleges)
- Első benyújtás
- 2014. jún. 13.
- Kezdés
- 2014. máj. 28.
- Elsődleges befejezés
- 2025. aug.
- Fő szponzor
- University of Texas Southwestern Medical Center
- Betegségek
- Hólyagrák, Vesedaganat, Tüdőrák, Prosztatarák
- NCT-szám
- NCT02170181
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 149
- 2014. máj. 28. és az elsődleges befejezés (2025. aug.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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.
- 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.
Kiket keres a vizsgálat
- 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.
- 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).
- Negative urine or serum pregnancy test for women of child-bearing potential
- Agreeable and willing to participate in expected protocol defined follow-up.
- Ability to understand and the willingness to sign a written informed consent.
- Registry participation does not exclude participation in clinical trials.
Életkor a regiszterben: 18 év – 99 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.