IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid... | Recruiting
IoN- Is Ablative Radio-iodine Neces... | Recruiting
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
IoN

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Medical Conditions
  • Thyroid Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01398085
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation is necessary for low risk differentiated thyroid cancer patients.
Research Details
  • Phase II: to determine if recruitment into a phase III trial is feasible, with a target of 10 patients per month during a minimum of 6 months (evaluated within months 7-18 of the trial).

    Phase III: to determine whether the 5-year disease-free survival rate among patients who do not have routine Radioactive iodine (RAI) ablation is non-inferior to those who do.
Phase
Phase 2/Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Radiation : I131 1.1 GBq

Study Arm Groups : Radioactive iodine (RAI) ablation Arm

Intervention Type
See Interventions above
Primary Outcome Measures
    Phase II: monthly patient accrual rates; Evaluated within months 7-18 of the trial; Phase III: 5-year disease-free survival (residual and recurrent); After follow up is complete (estimated year 8-9 of trial)
Secondary Outcome Measures
    Phase III: Cause Specific mortality; After follow up is complete (estimated year 8-9 of trial); Phase III: Loco-regional recurrence; After follow up is complete (estimated year 8-9 of trial); Phase III: Distant metastases; After follow up is complete (estimated year 8-9 of trial); Phase III: Quality of Life; After follow up is complete (estimated year 8-9 of trial); Phase III: Adverse events for all patients; After follow up is complete (estimated year 8-9 of trial); Phase III: Incidence of second primary tumours; After follow up is complete (estimated year 8-9 of trial)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
16 Years - N/A
Who Can Participate
Patients
Number of Participants
570
Participant Inclusion Criteria
    Inclusion Criteria:

    - R0 total thyroidectomy (in one or two stages, no residual disease present; Rx at the discretion of the MDT) within the last 6 months

    - Negative pregnancy test in women of child bearing potential

    - Aged 16 or over

    - WHO performance status 0 - 2, self-caring

    - Histological confirmation of differentiated thyroid carcinoma:

    MDT decision for inclusion based on overall clinico-pathological assessment

    - Papillary thyroid cancer

    - Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)

    - pT1a(m): all individual foci ≤1cm

    - pT1b and pT1b(m): >1-2cm

    - pT2 and pT2(m): >2-4cm

    - pT3 and pT3(m): >4cm

    - pT3 R0: any size with minimal extrathyroidal extension recommended by the MDT

    - pN0

    - pN1a

    - pNX

    - Encapsulated follicular variant of papillary thyroid cancer (EFVPTC) with capsular invasion only

    - Follicular thyroid cancer/ Hurthle cell cancer

    - minimally invasive with capsular invasion only (or up to four foci of possible invasion of intra - capsular vessels at the discretion of the MDT only)

    - pT1b: >1- 4 cm

    - pT3 R0: (up to 4cm only) with minimal extrathyroidal extension recommended by the MDT

    - Histological material available for Central Review

    - Willing to use contraception for the duration of the trial until 6 months post radioiodine treatment (for females) or 4 months post treatment (for males), if allocated to the ablation group.

    N.B. Multifocal tumours (≥2 foci) of all histological types should be designated with "(m)", and the size of the largest focus determines the classification (as described in the TNM 7th edition). For example, if there are two foci, one 0.8cm and the other 3cm, the classification is based on the 3cm focus; i.e. pT2(m).

    Exclusion Criteria:

    - pT1a - Papillary and Follicular carcinoma which is unifocal and ≤1cm in size

    - <4cm Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) with no capsular invasion

    - Anaplastic or medullary carcinoma

    - R1/R2 Thyroidectomy

    - Patients with:

    - pN1b

    - M1

    - Aggressive Papillary thyroid cancer with any of the following features:

    - Widely invasive

    - Poorly differentiated

    - Anaplastic

    - Tall cell

    - Columnar cell

    - Diffuse sclerosing variants

    - Follicular thyroid cancer/ Hürthle cell cancer with any of the following features:

    - Anaplastic

    - Widely invasive

    - Poorly differentiated

    - Tumours greater than 4cm

    - Incomplete resection or lobectomy

    - pT4 or macroscopic and microscopic tumour invasion of locoregional tissues or structures

    - Pregnant women or women who are breast feeding

    - Patients who have CT performed with iv contrast less than 2-3 months before ablation

    - Previous treatment for thyroid cancer (except surgery)

    - Previous malignancies with limited life expectancy or likely to interfere with the patient's ability to be able to comply with treatment and/or follow-up at least for 5 years

    - Dysphagia, Oesophageal stricture, Active gastritis,Gastric erosions, Peptic ulcer, Suspected reduced gastrointestinal motility

    - MDT decision against ablation or suitability for trail in the light of severe co-morbid condition/s:

    - Unstable angina

    - Recent myocardial infarction or cerebrovascular accident (CVA)

    - Severe labile hypertension

    - Any patient who cannot comply with radiation protection including:

    - patients with learning difficulties

    - patients with dementia

    - patients with a tracheostomy that require nursing care

    - patients requiring frequent nursing/ medical supervision
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Local Institution
London
Greater London
Royal Devon and Exeter Hospital
Exeter
England
EX2 5DW
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Maidstone Hospital
Maidstone
England
ME16 9QQ
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
GSK Investigational Site
Cambridge
CB2 0QQ
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich
IP4 5PD
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Nottingham
Nottinghamshire
NG5 1PB
Queen Elizabeth Hospital
Birmingham
Kennedy Institute Clinical Trials Unit, 4Wl, Charing Cross Hospital
London
W6 8RF
Brighton
BN2 5BE
Stevenage
SG1 4AB
Bristol
BS1 3NU
Newcastle upon Tyne
NE7 7DN
Broomfield Hospital
Chelmsford
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Norfolk and Norwich University Hospital
Norwich
Queen Alexandra Hospital
Portsmouth
Dorset County Hospital NHS Foundation Trust
Dorchester
DT1 2JY
Sheffield
S10 2SJ
Middlesbrough
TS4 3BW
Glasgow
G12 0YN
Cheltenham General Hospital and Gloucestershire Royal Infirmary
Cheltenham
Research Site
Wolverhampton
Novartis Investigative Site
Canterbury
CT1 3NG
Novartis Investigative Site
Southend-on-Sea
SS0 0RY
Derby
DE223NE
Velindre NHS Trust
Nantgarw
CF15 7QZ
The Royal Surrey County Hospital NHS Foundation Trust
Guildford
GU1 4JW
Trial Contact(s)
Primary Trial Contact
Steven Davis
020 7679 9241
Other Trial Contacts
Sharon Forsyth
020 7679 9264
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
UCL/10/0299
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

May 2012

Recruitment End Date

Nov 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

06 Jul 2011

Date updated in source

25 Oct 2016