We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms of thyroid and other endocrine glands
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Neuroblastoma is the most common paediatric extra-cranial solid tumour. Between a half and two thirds of patients will have high-risk disease. Despite highly intensive and varied treatments,patients still experience a low long-term survival of about 50% and chances of survival after disease recurrence are poor. The study aims to improve the survival and quality of life of children and young people with high-risk neuroblastoma and gain knowledge to improve the treatment of other patients in the future. The countries taking part in the study are: Denmark,Finland,Iceland,Norway,Sweden,Lithuania and UK. This trial is funded in the UK by CRUK. The treatment plan includes 2 intravenous injections,2 weeks apart,of a radioactive substance called 177Lutetium-DOTATATE (LuDO). LUDO targets somatostatin receptors,which are proteins present in the majority of neuroblastoma tumours in children. In a previous study with LUDO,the treatment was shown to be safe,but could not achieve the anticipated effect. The now proposed study (LuDO-N) aims to 1. confirm the dose,2. assess response to the treatment LUDO in patients with relapsed or refractory high-risk neuroblastoma,3. assess long term survival and 4. any treatment-related toxicity. This strategy requires a readiness for stem cell transplantation in all patients but is not expected to increase the risk of long-term side effects as the total radiation dose is unchanged. The duration of the trial is 5 years from end of treatment. The study will contribute to develop a new type of targeted treatment that,if shown to be effective,could replace the external beam radiation treatment in future international treatment protocols.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
Not fit enough to undergo proposed study treatment as assessed by clinician,considering precautions defined in the Summary of Medicinal Product Characteristics for 177-Lu LuDO. o Pregnancy. o Lactation. o Concurrent anti-tumour treatment. o Prior treatment with any radiolabelled somatostatin analogues. (Note: prior treatment with 131-I mIBG therapy is NOT a criterion for exclusion). o Any psychological,familial,sociological or geographical condition potentially hampering protocol compliance and follow-up. o Treatment with long-acting somatostatin analogues within 30 days prior to study treatment.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Karolinska University Hospital and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 54643
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
