SUPERMANNCT06804447
Pencil Beam Scanning Proton Beam Radiotherapy for the Management of Abdominal Neuroblastoma
StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
At risk: Primary completion moved 2 months later.
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Record History
All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗
Notable Recruitment opened Show 6 more changesShow less
- Start date changed from estimate of Mar 1, 2025 to Jun 4, 2026
- Eligibility criteria expanded, about 4 words
- Primary and study completion pushed from Mar 1, 2030 to May 1, 2030
- Study sites: 0 to 2
- Secondary endpoints: details revised at 3 of 11 entries
- Study description expanded, about 2 words
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Comparison of decision regarding radiotherapy technique selection at three time points of the patient and radiotherapy pathway
Timeframe: From date of first patient enrolment until the date of the last patient treatment (up to 36 months)
Secondary (11)
Measure and compare dose to target volume of PBT versus IMRT plans.
Measure and compare dose to organs at risk of PBT versus IMRT plans.
Measure and compare dose to normal tissues of PBT versus IMRT plans.
Number of PBT re-plans and reasons (including delays)
Number of patients requiring PBT to IMRT treatment modality conversions and the reasons for this.
Show 6 moreShow less
Evaluation of on-treatment imaging
Evaluation of on-treatment delivery data
Comparison of planned versus delivered dose for PBT plans
Local control at 2 years
Event free survival and overall survival at 2 years
Acute toxicity and late toxicity
Arms and interventions
RadiotherapyOther
Proton Beam Radiotherapy (PBT) or Intensity Modulated Radiotherapy (IMRT)
Radiation: Proton Beam Therapy
Sites
2 sites in 1 country