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High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer

NCT00415233 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2023-12-19

No results posted yet for this study

Summary

RATIONALE: Radioactive iodine uses radiation to kill tumor cells. Giving iodine I 131 with or without thyroid-stimulating hormone after surgery may kill any tumor cells that remain after surgery. It is not yet known which dose of iodine I 131 is more effective when given with or without thyroid-stimulating hormone in treating thyroid cancer.

PURPOSE: This randomized phase III trial is studying two different doses of iodine I 131 to compare how well they work when given with or without thyroid-stimulating hormone in treating patients who have undergone surgery for thyroid cancer.

Conditions

Interventions

BIOLOGICAL

recombinant thyroid-stimulating hormone

Recombinant thyroid stimulating hormone (rhTSH) should be given at a dose of 0.9mg by intramuscular injection on two consecutive days before ablation.

RADIATION

Radiodine ablation without rhTSH

Patients in this group do not receive rhTSH pre ablation.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Ujjal K. Mallick, MD · Newcastle-upon-Tyne Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-06-30
Completion
2025-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00415233 on ClinicalTrials.gov