Health TrialsbyHealthPanel

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

ConditionAbdominal Neuroblastoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorThe Christie NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant patient

Trial design

Design model

Single group

Treatments tested in this trial

  • Proton Beam Therapy

    Radiation

    Proton Beam Therapy

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: RadiotherapyOther 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

For patients who are dual planned, measure and compare dose to target volume, organs at risk and normal tissues of PBT versus IMRT plans (this is a descriptive endpoint).

Time frame
From date of first patient enrolment until the date of the last patient treatment (up to 36 months)
2

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

For patients who are dual planned, measure and compare dose to target volume, organs at risk and normal tissues of PBT versus IMRT plans (this is a descriptive endpoint).

Time frame
From date of first patient enrolment until the date of the last patient treatment (up to 36 months)
3

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

For patients who are dual planned, measure and compare dose to target volume, organs at risk and normal tissues of PBT versus IMRT plans (this is a descriptive endpoint).

Time frame
From date of first patient enrolment until the date of the last patient treatment (up to 36 months)
4

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

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Christie NHS Foundation Trust

Lead sponsor

University College London Hospitals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: