Contact information
Type
Public
Primary contact
Ms Louise Moeller
ORCID ID
Contact details
Children’s Cancer Trials Team
Cancer Research UK Clinical Trials Unit (CRCTU)
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 415 1060
imat@trials.bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
33136
Study information
Scientific title
A randomised phase I/II study of Intensity Modulated Arc Therapy techniques in abdominal neuroblastoma
Acronym
IMAT
Study hypothesis
The aim of this study is to determine the radiotherapy dose, possibly higher than is currently standard and feasible, delivered by either IMAT or conventional radiotherapy techniques, for use in a subsequent international randomised phase III study.
Ethics approval
London - Hampstead Research Ethics Committee, 21/12/2016, ref: 16/LO/2186
Study design
Randomised; Interventional; Design type: Treatment, Radiotherapy
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Children's Cancer and Leukaemia; UKCRC code/ Disease: Cancer/ Malignant neoplasms of ill-defined, secondary and unspecified sites
Intervention
Participants will be randomised via paper-based telephone randomisation until the online remote database is live (https://www.cancertrials.bham.ac.uk/IMATlive ). They will be randomised in a 1:1 ratio according to a computerised minimisation algorithm, developed by the Trial Office, stratified according to MYCN amplification, Stage L2 or M and completeness of surgery.
Arm A: Participants receive a dose of 21 Gy in 14 fractions over 3 weeks
Arm B: Participants receive a dose of 36 Gy in 24 Fractions over 5 weeks
The centre will then have four weeks after a planning scan to define treatment area and work out a treatment plan for both IMAT and conventional radiotherapy and a central review board will decide on the best treatment for the patient.
All participants are followed up for the 30 days following the end of treatment to monitor for acute toxicity. Clinical assessments are every six months until two years post randomisation date. Two years post randomisation there will be a local control assessment. Assessment as per local practise between 2-5 years post randomisation. Five years post randomisation there is a long term toxicity assessment.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The actual dose delivered to patients in Gy, covering total Gy given and in how many fractions is captured by form following end of treatment.
Secondary outcome measures
1. Acute toxicity is assessed using information acquired by telephone consultation or clinic visit at least weekly for the thirty days following the end of treatment
2. Local control is assessed as per standard practice (mIBG scans and cross-sectional imaging are typically performed) at two years after randomisation. In the absence of any other imaging modality being indicated for other purposes, ultrasound examination or MRI scan is preferred to avoid additional radiation exposure.
3. Long term side effects are recorded at 5 years after the patient was randomised according to the Late Toxicity RTOG scoring system. This information will be collected during routine clinic visits; no trial specific visits are required.
4. Event-free survival (EFS) and overall survival (OS) are captured using case report forms at each follow up visit/phone call whether the patient is still alive and whether there is progression/recurrence. This is captured weekly post treatment up until the end of thirty days post treatment, then every six months until 2 years post randomisation, then as per local practise from 2 years up until 5 years post randomisation.
Overall trial start date
01/06/2012
Overall trial end date
21/02/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Any patient with high-risk neuroblastoma of the abdominal or pelvic regions who requires radical radiotherapy
2. Fit to receive radical radiotherapy
3. Aged 18 months or over at diagnosis
4. Informed consent from patient, parent or guardian
5. Documented negative pregnancy test for female patients of child bearing potential
6. Patient agrees to use effective contraception during treatment period (patients of child bearing age)
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Participant exclusion criteria
Pregnant patient.
Recruitment start date
21/02/2017
Recruitment end date
21/02/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College Hospital
235 Euston Road
Fitzrovia
London
NW1 2BU
United Kingdom
Trial participating centre
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Belfast City Hospital
51 Lisburn Road
Belfast
BT9 7AB
United Kingdom
Trial participating centre
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Trial participating centre
City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Trial participating centre
Clatterbridge Cancer Centre
Lower Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom
Trial participating centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Trial participating centre
Gartnavel Hospital
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Trial participating centre
Christie NHS Foundation Trust
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Trial participating centre
The Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Trial participating centre
The Royal Marsden Hospital
203 Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Trial participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
St. James University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Trial participating centre
Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom
Trial participating centre
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
Sponsor information
Organisation
University of Birmingham
Sponsor details
Research Support Group
Aston Webb Building (Block B)
Birmingham
B15 2TT
United Kingdom
+44 1214 158011
researchgovernance@contacts.bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication is intended to be in peer-reviewed scientific journals, internal reports, conference presentations, website publications, submission to regulatory authorities.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
21/02/2026
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN10746820_PROTOCOL_v3.0_15May2018.pdf uploaded 22/07/2020