Trial record 1 of 1 for:
NCT01398085
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients (IoN)
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| ClinicalTrials.gov Identifier: NCT01398085 |
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Recruitment Status :
Active, not recruiting
First Posted : July 20, 2011
Last Update Posted : May 10, 2023
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Sponsor:
University College, London
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thyroid Cancer | Radiation: I131 1.1 GBq | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 504 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients |
| Study Start Date : | May 2012 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | March 2031 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Radioactive iodine (RAI) ablation Arm
Patients will be randomised to receive Radioactive iodine (RAI) ablation I131 1.1 GBq
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Radiation: I131 1.1 GBq
Radio-iodine
Other Name: Sodium iodide capsule |
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No Intervention: No Radioactive iodine (No-RAI) ablation
Patients will be randomised to receive No Radioactive iodine (No-RAI) ablation
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Primary Outcome Measures :
- Phase II: monthly patient accrual rates [ Time Frame: Evaluated within months 7-18 of the trial ]To determine if recruitment into a phase III trial is feasible
- Phase III: Disease-free thyroid specific survival [ Time Frame: From randomisation until recurrence or death from thyroid cancer ]DFS measured from randomisation until date of recurrence or death from thyroid cancer
Secondary Outcome Measures :
- Phase III: Mortality (cause and date of death) [ Time Frame: From randomisation until death ]Cause and date of death
- Phase III: Occurrence of loco-regional recurrence or metastatic disease [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]Both groups will be compared to ascertain if radio-iodine results in a statistically significant reduction in risk in developing loco-regional recurrence in the low risk subgroup of patients.
- Phase III: Stage of cancer at the time of recurrence, and the ability to treat this successfully [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]Both groups will be compared to ascertain if radio-iodine results in a statistically significant difference in the stage of cancer at the time of recurrence, and the ability to treat this successfully.
- Phase III: Health-related quality of life [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]Quality of Life
- Phase III: Adverse events for all patients [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]Adverse events will be collected for patients in both groups during treatment and the groups compared during analysis.
- Phase III: Further neck surgery [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]The number of further neck surgeries will be collected for patients in both groups during follow up and the groups compared during analysis.
- Phase III: Further RAI ablations [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]Further RAI ablation and the reasons for this
- Phase III: Cost-effectiveness [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]Costs of treatment for both groups will be collected for duration of trial to see if there is a difference between the two.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
TNM eligibility is assessed against TNM7 (7th edition 2009) or TNM8 (8th edition 2017, in use in the UK from 01/01/2018).
Eligibility Criteria using TNM7:
Inclusion criteria:
- Histological confirmation of well differentiated thyroid carcinoma: MDT decision for inclusion based on overall clinico-pathological assessment is critical.
- 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
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Papillary thyroid cancer (PTC):
- Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
- pT1a (≤1cm) unifocal with positive level VI lymph nodes (pN1a)
- pT1a(m): all individual foci ≤1cm
- pT1b and pT1b(m): >1-2cm
- pT2 and pT2(m): >2-4cm
- pT3 and pT3(m): >4cm confined to the thyroid
- pT3 R0 +/- (m): any size with minimal ETE if recommended by the MDT
- pN0
- pN1a
- pNX
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Follicular thyroid cancer (FTC) (including oncocytic or Hürthle cell cancer):
o minimally invasive FTC -which are considered low risk and are recommended by the specialist MDT based on overall clinico-pathological assessment
- pT1b and pT2: >1-4cm intrathyroidal
- pT3 R0:any size up to 4 cm with minimal ETE if recommended by the MDT
- Histological material available for Central Review (see section 9.7)
- 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) (see section 6.4.2), if allocated to the ablation group.
NB: 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, without any positive nodes or unfavourable clinical features, treated by lobectomy.
- Up to 4cm non-invasive Encapsulated Follicular Variant of Papillary Thyroid Cancer (eFVPTC) with no capsular or vascular invasion (>4 cm can be included at the discretion of the MDT)
- non-invasive follicular tumour with papillary-like nuclei (NIFTP)
- Anaplastic, poorly differentiated or medullary carcinoma
- R1 or R2 thyroidectomy
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Patients with:
- pN1b
- M1
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Aggressive Papillary thyroid cancer with any of the following features:
- Widely invasive
- Poorly differentiated
- Anaplastic
- Tall cell
- Columnar cell
- Diffuse sclerosing variants
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Follicular thyroid cancer/Hürthle cell cancer with any of the following features:
- Tumours greater than 4cm
- Widely invasive
- Poorly differentiated
- Anaplastic
- Incomplete resection or lobectomy
- pT4a and pT4b or macroscopic and microscopic tumour invasion of loco-regional tissues or structures
- Pregnant women or women who are breast feeding
- Patients who have had CT performed with iv contrast less than 2-3 months before ablation
- Previous treatment for thyroid cancer (except surgery in last 6 months)
- 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 for at least 5 years
- The following GI conditions: dysphagia, oesophageal stricture, active gastritis, gastric erosions, peptic ulcer, suspected reduced gastrointestinal motility
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MDT decision against ablation or suitability for trial in light of severe co-morbid condition/s including:
- 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
Eligibility Criteria using TNM8:
Inclusion criteria:
- Histological confirmation of well differentiated thyroid carcinoma: MDT decision for inclusion based on overall clinico-pathological assessment is critical.
- 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 (PTC):
- Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
- pT1a (≤1cm) unifocal with positive level VI lymph nodes (pN1a)
- pT1a(m): all individual foci ≤1cm
- pT1b and pT1b(m): >1-2cm
- pT2 and pT2(m): >2-4cm
- pT3a and pT3a(m): >4cm confined to thyroid
- pT1a/1b/2/3 (where minimal microscopic extra thyroidal extension (ETE) does not change the T score) +/- (m): any size with minimal ETE if recommended by the MDT
- pN0
- pN1a
- pNX
-
Follicular thyroid cancer (FTC) (including oncocytic or Hürthle cell cancer):
o minimally invasive FTC -which are considered low risk and are recommended by the specialist MDT based on overall clinico-pathological assessment
- pT1b and pT2: >1-4cm intrathyroidal
- pT1a/1b/2/3a (where minimal microscopic ETE does not change the T score): any size up to 4 cm with minimal ETE if recommended by the MDT
- Histological material available for Central Review (see section 9.7)
- 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) (see section 6.4.2), if allocated to the ablation group.
Exclusion criteria:
- pT1a - Papillary and Follicular carcinoma which is unifocal and ≤1cm in size, without any positive nodes or unfavourable clinical features, treated by lobectomy.
- Up to 4cm non-invasive Encapsulated Follicular Variant of Papillary Thyroid Cancer (eFVPTC) with no capsular or vascular invasion (>4 cm can be included at the discretion of the MDT)
- non-invasive follicular tumour with papillary-like nuclei (NIFTP)
- Anaplastic, poorly differentiated or medullary carcinoma
- R1 or R2 thyroidectomy
-
Patients with:
- pN1a with level VII involvement
- 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:
- Tumours greater than 4cm
- Widely invasive
- Poorly differentiated
- Anaplastic
- Incomplete resection or lobectomy
- pT3b, pT4a and pT4b or macroscopic and microscopic tumour invasion of loco-regional tissues or structures
- Pregnant women or women who are breast feeding
- Patients who have had CT performed with iv contrast less than 2-3 months before ablation
- Previous treatment for thyroid cancer (except surgery in last 6 months)
- 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 for at least 5 years
- The following GI conditions: dysphagia, oesophageal stricture, active gastritis, gastric erosions, peptic ulcer, suspected reduced gastrointestinal motility
-
MDT decision against ablation or suitability for trial in light of severe co-morbid condition/s including:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398085
Locations
Show 32 study locations
Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
| Principal Investigator: | Ujjal Mallick, MBBS, Master of Surgery, FRCR | Newcastle-upon-Tyne Hospitals NHS Foundation Trust | |
| Study Director: | Jonathan Ledermann | University College London (Joint UCLH & UCL Biomedical Research Unit) |
Additional Information:
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT01398085 |
| Other Study ID Numbers: |
UCL/10/0299 2011-000144-21 ( EudraCT Number ) Cancer Research UK ( Other Grant/Funding Number: CRUK/11/010 ) ISRCTN ( Registry Identifier: ISRCTN80416929 ) |
| First Posted: | July 20, 2011 Key Record Dates |
| Last Update Posted: | May 10, 2023 |
| Last Verified: | May 2023 |
Keywords provided by University College, London:
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Papillary thyroid carcinoma Follicular thyroid carcinoma Hurthle cell carcinoma of the thyroid Iodine Radioisotopes |
Additional relevant MeSH terms:
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Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms |