Status:
COMPLETED
Whole Brain Radiation Therapy Alone vs. Radiosurgery for SCLC Patients With 1-10 Brain Metastases
Lead Sponsor:
Juergen Debus
Collaborating Sponsors:
Heidelberg University
Conditions:
SCLC
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients suffering from small cell lung cancer (SCLC) are at high risk for developing brain metastases (BM). To prevent a clinical manifestation of preexisting microscopic brain dissemination, prophyl...
Detailed Description
Scientific Background: Patients suffering from BM from SCLC have a poor prognosis with a median survival ranging between 2-14 months. Treatment options for BM in SCLC are usually limited to WBRT, ster...
Eligibility Criteria
Inclusion
- histologically confirmed small cell lung cancer (SCLC)
- Magentic resonance (MR)-imaging confirmed cerebral metastases (no resection, max. number of 10)
- age ≥ 18 years of Age
- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- Patients who have not yet recovered from acute high-grade toxicities of prior therapies
- Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials, respectively
- MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)
- Karnofsky score (KPS) \<60
- Simultaneous cytotoxic chemotherapy
- Last application of chemotherapy/immunotherapy/targeted therapy \<1 week before cerebral radiotherapy
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03297788
Start Date
December 1 2017
End Date
December 1 2023
Last Update
January 5 2024
Active Locations (1)
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1
University Hospital of Heidelberg, Department of Radiation Oncology
Heidelberg, Germany, 69120