NCT03297788Completed
Whole Brain Radiation Therapy Alone vs. Radiosurgery for SCLC Patients With 1-10 Brain Metastases
Whole Brain Radiation Therapy (WBRT) Alone Versus Radiosurgery (SRS) for Patients With 1-10 Brain Metastases From Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 5 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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, prophylactic cranial irradiation (PCI) is offered to both limited and extensive disease patients, if they respond to first line regime, thus being at risk or at chance to develop clinical brain metastases. However, up to 10-15% of patients present with BM at initial diagnosis. If MRI is used as a diagnostic tool for initial staging the number even increases up to 15-20%. Additionally, between 40 - 50% of patients develop BM until time of death and the risk of developing BM further increases with prolonged survival. Treatment options are usually limited to WBRT and palliative chemotherapy but the actual effect of therapeutic WBRT has mainly been studied in small retrospective and nonrandomized studies. WBRT has been established as the treatment standard in patients with cerebral metastases from SCLC, however, it has only modest efficacy. Results might be improved by additional dose escalation. A SRS to cerebral metastases may be indicated in patients with intracranial disease, and the current protocol is aimed at exploring the neurocognition and efficacy of SCLC in patients with brain metastases treated with SRS or WBRT. The present trial aims to exploratory investigate the treatment response to ´conventional whole brain radiotherapy´ (WBRT) and ´stereotactic radiotherapy´(SRS) in SCLC patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 19 Sept 2017
- Start date
- 1 Dec 2017
- Primary completion date
- 1 Oct 2023
- Lead sponsor
- Juergen Debus
- Diseases
- Lung cancer
- NCT number
- NCT03297788
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 1 Dec 2017 to the primary completion date, 1 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous radiotherapy of the brain
- Patients who have not yet recovered from acute high-grade toxicities of prior therapies
- Simultaneous cytotoxic chemotherapy
- Last application of chemotherapy/immunotherapy/targeted therapy \<1 week before cerebral radiotherapy
Other illness
- MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)
Age
- 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
Other
- refusal of the patients to take part in the study
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials, respectively
- Karnofsky score (KPS) \<60
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Heidelberg, Department of Radiation Oncology Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.