NCT04516070Fut, nem toboroz2. fázis
Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis
Stereotactic Radiosurgery (SRS) as Definitive Management for a Limited Number of Small Cell Lung Cancer (SCLC) Brain Metastasis
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 14.
Rövid összefoglaló (regiszter, angolul)
This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may result in side effects affecting the nervous system. Stereotactic radiosurgery only targets areas of the brain that are suspected to be affected by the disease. The purpose of this trial is to learn if and how patients' brain functions are affected by the use of stereotactic radiosurgery rather than whole brain radiation therapy in managing brain metastasis caused by small cell lung cancer. Stereotactic radiosurgery may help patients avoid nervous system side effects caused by whole brain radiation therapy.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 55 (tényleges)
- Első benyújtás
- 2020. aug. 13.
- Kezdés
- 2020. aug. 28.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- M.D. Anderson Cancer Center
- Betegségek
- Tüdőrák
- NCT-szám
- NCT04516070
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Bevont résztvevők: 55
- 2020. aug. 28. és az elsődleges befejezés (2026. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Patients are excluded if they have a history of metastatic cancer in addition to small cell malignancy or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded
- Patients are excluded if there is radiographic evidence of leptomeningeal disease
- Patients are excluded if there are malignant cells identified in the CSF on cytologic examination
- Patients are excluded if they are unable to obtain an MRI scan for any other reason, including gadolinium allergy
- Patients are excluded with medical history of a psychiatric or neurologic illness, or other comorbidities believed to affect cognitive function. Subjects with neurocognitive deficit related to brain metastasis are an exception to this criterion and may qualify for the study.
Laborértékek
- Female patients of childbearing age are excluded if they are pregnant as determined with a urine or serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding
Egyéb
- Patients are not excluded for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the CSF
Kiket keres a vizsgálat
- Patients must have Eastern Cooperative Oncology Group (ECOG) =\< 3
- All patients must have histologic evidence suggesting small cell lung cancer. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc.). Cytology-alone is not an acceptable method of diagnosis.
- Patient has 10 or less brain metastases on contrast-enhanced brain MRI scan obtained no greater than 6 weeks prior to study registration. Biopsy of brain metastasis is not required. A patient may be enrolled with zero brain metastasis assuming that the SRS is to be directed at the post-operative surgical cavity of a resected metastasis.
- Patients must be eligible to have all lesions treated with stereotactic radiosurgery as determined by the study radiation oncologist
- Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
- Patients should have normal coagulation \[International Normalized Ratio (INR) \< 1.3\]. within 28 days of enrollment.
- Patient's primary language is English
- No prior radiation therapy to the brain, including WBRT, PCI, or SRS
- Performance Status Assessment
- Standard ECOG performance status assessment will be used and determined by the treating physician
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| M D Anderson Cancer Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Houston | Egyesült Államok | Ismeretlen állapot |
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