UnknownPhase 3

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

United Kingdom438 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range

16 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed differentiated thyroid cancer * T1-T3, Nx, N0, N1, M0 disease * Has undergone one- or two-stage total thyroidectomy with or without lymph node dissection * All known tumor resected (R0) * Requires radioiodine remnant ablation * Does not require mandatory recombinant thyroid-stimulating hormone * No Hurthle cell carcinoma or aggressive variants, including any of the following: * Tall cell, insular, poorly differentiated disease with diffuse sclerosing * Anaplastic or medullary carcinoma PATIENT CHARACTERISTICS: * WHO performance status 0-2 * No severe comorbid conditions including, but not limited to, any of the following: * Unstable angina * Recent heart attack or stroke * Severe labile hypertension * Dementia * Concurrent dialysis * Tracheostomy needing care * Learning difficulties * Inability to comply with radiation protection issues * Requirement for frequent nursing or medical supervision that puts staff at risk for unacceptable radiation exposure * No other cancers except basal cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use effective contraception during and for 6 months after radioiodine remnant ablation * Fertile male patients must use effective contraception during and for 4 months after radioiodine remnant ablation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 mon…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with successful remnant ablation at 6-9 months

Timeframe: 6-9 months

Trial details

NCT IDNCT00415233

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Head and Neck Cancer trials