Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 15, 2026
Date Accepted: Aug 28, 2026
[177Lu]Lu-DOTATATE Molecular Radiotherapy During Induction Chemotherapy for First-Line Stage 4 High-Risk Neuroblastoma in South African Children: Protocol for a Phase I Randomised Controlled Trial (LuDO-SA Trial)
ABSTRACT
Background:
The metastatic response rate for stage IV high-risk neuroblastoma for induction chemotherapy in South Africa is lower than similar regimens in well-resourced settings. Augmenting current induction chemotherapy regimens with molecular radiotherapy without increasing toxicity is an attractive systemic treatment in radio-isotope-avid tumours, especially in resourced constrained settings. Clinical trials of [177Lu]Lutetium DOTATATE have mainly focused on refractory or relapsed high-risk neuroblastoma with disappointing results.
Objective:
A phase one clinical randomised controlled trial in South Africa investigates the inclusion of [177Lu]Lu-DOTATATE molecular radiotherapy during induction chemotherapy for first-line stage IV high-risk neuroblastoma in South African children to achieve metastatic remission. The study additionally evaluates the feasibility and dose-limiting toxicity grading of an additional single dose [177Lu]Lutetium DOTATATE to induction chemotherapy during neuroblastoma treatment.
Methods:
The LuDO-SA trial is a phase one, open label, multi-center, two arm, randomised control clinical trial (South African National Trial Registry DOH-27-082022-5449). Children aged 18 months to 18 years are eligible. The trial is conducted by the South African Association for Paediatric Haemato-Oncology’s Neuroblastoma Working Group. Stellenbosch University is the primary investigator site. Four academic hospitals participate in the trial which started recruitment in January 2023 and are supported by national and international organisations with the provision of [177Lu]Lutetium DOTATATE and with logistics.
Results:
The paediatric use of [177Lu]Lu-DOTATATE molecular radiotherapy in South Africa is limited to non-neuroblastoma neurogenic tumours. With approval from the South African Health Products Regulatory Agency (SAHPRA) the product is used in the experimental (interventional) arm as a single dose administration in addition to standard induction chemotherapy in stage IV high risk neuroblastoma. The trial is still recruiting with an end date for recruitment by December 2026.
Conclusions:
This publication documents the protocol of the LuDO-SA Trial. The rationale and design of the trial in a resource limited setting and the use in first-line regimens are discussed and the status of international [177Lu]Lu-DOTATATE molecular radiotherapy trials are summarised. Clinical Trial: South African National clinical trials Registry DOH-27-082022-5449
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