Condition category
Cancer
Date applied
13/02/2017
Date assigned
13/02/2017
Last edited
06/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.