a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS

February 14, 2024 updated by: Paivi Halonen, Helsinki University Central Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: RAILESS
Railess group including patients to bw followed up wihtout postoperative radioiodine treatment
Active Comparator: rairinn
THose patients receiving radioiodine treatment according to the normal treatment practice at that time
Other: With radioiodine treatment
Postoperative radioiodine not given
Other Names:
  • RAILESS
Procedure: With postoperative radioiodine treatment
Postoperative radioiodine given
Other Names:
  • RAIRINN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free situation during follow-up event free /disease free
Time Frame: 10 yrs
Without any treatmment
10 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Päivi Halonen, MD, Medical Oncologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAILESS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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