a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS

NCT ID: NCT06271044

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 .
Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking.

Study Groups

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RAILESS

Railess group including patients to bw followed up wihtout postoperative radioiodine treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

rairinn

THose patients receiving radioiodine treatment according to the normal treatment practice at that time

Group Type ACTIVE_COMPARATOR

With radioiodine treatment

Intervention Type OTHER

Postoperative radioiodine not given

With postoperative radioiodine treatment

Intervention Type PROCEDURE

Postoperative radioiodine given

Interventions

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With radioiodine treatment

Postoperative radioiodine not given

Intervention Type OTHER

With postoperative radioiodine treatment

Postoperative radioiodine given

Intervention Type PROCEDURE

Other Intervention Names

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RAILESS RAIRINN

Eligibility Criteria

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Inclusion Criteria

* low risk papillary intrathyroidal thyroid cancer with diameter of 11-20mm
* no lymphnode metastases

Exclusion Criteria

* high risk papillary cancer
* mutlifocal papillary cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paivi Halonen

Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Päivi Halonen, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Oncologist

Other Identifiers

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RAILESS

Identifier Type: -

Identifier Source: org_study_id

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