to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mmNCT06271044
a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS
A study testing With radioiodine treatment and With postoperative radioiodine treatment in people with to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm, run by Helsinki University Central Hospital.
Trial summary
To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm
- What is being tested?
- With radioiodine treatment and With postoperative radioiodine treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low risk papillary intrathyroidal thyroid cancer with diameter of 11-20mm
- no lymphnode metastases
Who cannot join
- high risk papillary cancer
- mutlifocal papillary cancer
About this study
Official title: Reducing Radioiodine Treatment in Low Risk Papillary Thyroid Cancer
To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level.
Read the detailed description
The purpose of the study : to enroll about 50 patients operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level.
Methods: either to follow-up patients according to the study protocol without radioiodine treatment or to give a radioiodine treatment with a dose of 1.1 GBq according to the normal Finnish treatment protocol for papillary thyroid cancer to those patients who themselves preferred to have a normal postoperative treatment.
- Being tested
- With radioiodine treatment, With postoperative radioiodine treatment
- Keywords
- radioiodine treatment, low risk thyroid cancer, papillary thyroid cancer
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With radioiodine treatmentOther
Also called RAILESS
Postoperative radioiodine not given
With postoperative radioiodine treatmentProcedure or surgery
Also called RAIRINN
Postoperative radioiodine given
| Study group | Role | What they receive |
|---|---|---|
| RAILESS | No intervention | Railess group including patients to bw followed up wihtout postoperative radioiodine treatment |
| rairinn | Active comparator | THose patients receiving radioiodine treatment according to the normal treatment practice at that time Receives: Other: With radioiodine treatment; Procedure: With postoperative radioiodine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free situation during follow-up event free /disease free
Without any treatmment
Measured: 10 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study startOct 2014
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mmStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with low risk papillary thyroid cancer either received a radioiodine treatment according to the normal Finnish treatment schedule or were schedulded for only follow-up .
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paivi Halonen, Helsinki University Central Hospital
- Investigators
- Päivi Halonen, MD, Principal investigator, Medical Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271044
- Sponsor's protocol ID
- RAILESS
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Radioiodine Treatment in Low Risk Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06271044
- Acronym / sponsor ID
- RAILESS
- Keywords
- radioiodine treatment, low risk thyroid cancer, papillary thyroid cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level.
Detailed description
The purpose of the study : to enroll about 50 patients operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level.
Methods: either to follow-up patients according to the study protocol without radioiodine treatment or to give a radioiodine treatment with a dose of 1.1 GBq according to the normal Finnish treatment protocol for papillary thyroid cancer to those patients who themselves preferred to have a normal postoperative treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with low risk papillary thyroid cancer either received a radioiodine treatment according to the normal Finnish treatment schedule or were schedulded for only follow-up .
| Arm | Type | Receives |
|---|---|---|
| RAILESS | No intervention | –Railess group including patients to bw followed up wihtout postoperative radioiodine treatment |
| rairinn | Active comparator | Other: With radioiodine treatment, Procedure: With postoperative radioiodine treatmentTHose patients receiving radioiodine treatment according to the normal treatment practice at that time |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- low risk papillary intrathyroidal thyroid cancer with diameter of 11-20mm
- no lymphnode metastases
Key exclusion criteria (2 listed)
- high risk papillary cancer
- mutlifocal papillary cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With radioiodine treatmentAlso: RAILESSPostoperative radioiodine not given | Other | rairinn |
| With postoperative radioiodine treatmentAlso: RAIRINNPostoperative radioiodine given | Procedure or surgery | rairinn |
Primary outcome
Event free situation during follow-up event free /disease free
Time frame: 10 yrs
Without any treatmment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Päivi Halonen, MD principal investigator
Medical Oncologist
Questions about this trial
What is this clinical trial studying?
A study testing With radioiodine treatment and With postoperative radioiodine treatment in people with to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free situation during follow-up event free /disease free (time frame: 10 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.