Pencil Beam Scanning Proton Beam Radiotherapy for the Management of Abdominal Neuroblastoma

NCT06804447 | Not Yet Recruiting

• 2 other identifiers: CFTSp218 (03)NPBT3211
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Proton Beam Therapy (PBT) and Evaluative Commissioning in Protons (ECIP): PBT is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom, in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT. ECIP is a programme of studies exploring the role of PBT in different types of cancer funded by NHS England. ECIP studies are not randomised, eligible patients will be offered PBT. Any eligible UK patient can be referred, and accommodation is available for patients who don't live close to a PBT centre. The main benefit of PBT, compared with standard photon radiotherapy, is predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects. SUPERMAN: SUPERMAN is a study within the ECIP programme. It is sometimes not entirely clear whether PBT or photon radiotherapy is better for the treatment of a patient with abdominal neuroblastoma. The aim of SUPERMAN is to choose the best radiotherapy technique and to better understand how to monitor and adapt PBT for these patients.

Conditions

Abdominal Neuroblastoma

Keywords

Proton Beam Therapy; Abdominal Neuroblastoma; Evaluative Commissioning

Outcome Measures

Primary Outcomes (1)

• Comparison of decision regarding radiotherapy technique selection at three time points of the patient and radiotherapy pathway

  Comparison of decision regarding radiotherapy technique selection (PBT vs IMRT) at three time points of the patient and radiotherapy pathway: 1. Selection 1 - Proposed modality at time of referral - Pre-planning 2. Selection 2 - Post planning 3. Selection 3 - Post completion of radiotherapy

  From date of first patient enrolment until the date of the last patient treatment (up to 36 months)

Secondary Outcomes (11)

• Measure and compare dose to target volume of PBT versus IMRT plans.

  From date of first patient enrolment until the date of the last patient treatment (up to 36 months)

• Measure and compare dose to organs at risk of PBT versus IMRT plans.

  From date of first patient enrolment until the date of the last patient treatment (up to 36 months)

• Measure and compare dose to normal tissues of PBT versus IMRT plans.

  From date of first patient enrolment until the date of the last patient treatment (up to 36 months)

• Number of PBT re-plans and reasons (including delays)

  From date of first patient enrolment until the date of the last patient treatment (up to 36 months)

• Number of patients requiring PBT to IMRT treatment modality conversions and the reasons for this.

  From date of first patient enrolment until the date of the last patient treatment (up to 36 months)

Study Arms (1)

Radiotherapy

OTHER

Proton Beam Radiotherapy (PBT) or Intensity Modulated Radiotherapy (IMRT)

Radiation: Proton Beam Therapy

Interventions

Proton Beam Therapy RADIATION

Proton Beam Therapy

Radiotherapy

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with histologically confirmed abdominal or abdominal-pelvic neuroblastoma who are eligible and fit for radical radiotherapy.
• Written informed consent from patient, parent or guardian - this includes consent for the minimum baseline, treatment and follow up assessments; and for their data to be stored and used for research, within the appropriate Proton Clinical Outcomes Units and NHS Proton Registry.
• Patients registered female at birth of childbearing potential agree to use effective contraception between the planning Computed Tomography (CT) scan and the end of treatment.

You may not qualify if:

• Pregnant patient

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University College London Hospitals: collaborator

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Central Study Contacts

Pei Lim, BM, MSc, MD(Res), MRCP, FRCR

CONTACT

0044 (0)203 447 4437; pei.lim@nhs.net

Sally Falk, BSc

CONTACT

0044 (0)161 9187172; sally.falk@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SUPERMAN is a multicentre prospective study assessing the feasibility of using an algorithm based on pre-defined clinical characteristics to appropriately select patients with abdominal or abdominal-pelvic neuroblastoma for PBT treatment. This study will also assess delivered dosimetry of PBT plans with adaptive treatment strategies.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: February 3, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 3, 2025

Record last verified: 2025-01