IMAT-Neuroblastoma

ISRCTN	ISRCTN10746820
DOI	https://doi.org/10.1186/ISRCTN10746820
Protocol serial number	CPMS 33136
Sponsor	University of Birmingham
Funder	Cancer Research UK

Submission date: 13/02/2017
Registration date: 13/02/2017
Last edited: 17/02/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-intensity-modulated-arc-therapy-for-people-with-neuroblastoma-imat

Contact information

Ms Louise Moeller
Public

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

Phone	+44 121 415 1060
Email	imat@trials.bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomized; Interventional; Design type: Treatment, Radiotherapy
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised Phase I/II study of Intensity Modulated Arc Therapy techniques in abdominal neuroblastoma
Study acronym	IMAT
Study objectives	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(s)	London - Hampstead Research Ethics Committee, 21/12/2016, ref: 16/LO/2186
Health condition(s) or problem(s) studied	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 the 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 6 months until 2 years post-randomisation date. Two years post randomisation there will be a local control assessment. Assessment as per local practice between 2-5 years post-randomisation. At 5 years post-randomisation there is a long-term toxicity assessment.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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 2 years after randomisation. In the absence of any other imaging modality being indicated for other purposes, an 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 6 months until 2 years post-randomisation, then as per local practise from 2 years up until 5 years post-randomisation.
Completion date	28/12/2025

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Months
Sex	All
Target sample size at registration	50
Total final enrolment	50
Key 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 childbearing potential 6. Patient agrees to use effective contraception during the treatment period (patients of childbearing age)
Key exclusion criteria	Pregnant patient
Date of first enrolment	21/02/2017
Date of final enrolment	14/08/2020

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland
Wales

Study participating centres

University College Hospital

235 Euston Road
Fitzrovia
London
NW1 2BU
United Kingdom

Addenbrookes Hospital

Hills Road
Cambridge
CB2 0QQ
United Kingdom

Belfast City Hospital

51 Lisburn Road
Belfast
BT9 7AB
United Kingdom

Churchill Hospital

Old Road
Headington
Oxford
OX3 7LE
United Kingdom

City Hospital

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Clatterbridge Cancer Centre

Lower Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom

Freeman Hospital

Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Gartnavel Hospital

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Christie NHS Foundation Trust

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

The Queen Elizabeth Hospital

Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

The Royal Marsden Hospital

203 Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Southampton General Hospital

Tremona Road
Southampton
SO16 6YD
United Kingdom

St. James University Hospital

Beckett Street
Leeds
LS9 7TF
United Kingdom

Velindre Cancer Centre

Velindre Road
Cardiff
CF14 2TL
United Kingdom

Weston Park Hospital

Whitham Road
Sheffield
S10 2SJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			20/06/2024	No	Yes
Protocol file	version v3.0	15/05/2018	22/07/2020	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN10746820_PROTOCOL_v3.0_15May2018.pdf: uploaded 22/07/2020

Editorial Notes

17/02/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 21/02/2019 to 14/08/2020.
2. The overall study end date was changed from 21/02/2025 to 28/12/2025.
3. Total final enrolment added.
20/06/2024: Link to plain English results on CRUK added.
08/11/2023: The study team confirmed that no updates were required to the study record.
22/07/2020: Uploaded protocol (not peer reviewed) as an additional file.
06/06/2017: Cancer Help UK lay summary link added to plain English summary field.
04/05/2017: The recruitment end date has been updated from 21/08/2019 to 21/02/2019.