Neoplasms

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Head and Neck Neoplasms

Adenocarcinoma, Follicular

Endocrine System Diseases

Endocrine Gland Neoplasms

Papillary Thyroid Carcinoma

Thyroid Cancer, Follicular

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Hormones

Iodine

Cadexomer iodine

Hormone Antagonists

Patients receive 1.1GBq dose of radioactive iodine and rhTSH

Patients receive 3.2GBq dose of radioactive idodine and rhTSH

Patients only receive 1.1GBq dose of radioactive iodine and no rhTSH

Patients only receive 3.2GBq dose of radioactive iodine and no rhTSH

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

recombinant thyroid-stimulating hormone

Patients in this group do not receive rhTSH pre ablation.

Radiodine ablation without rhTSH

Ujjal K. Mallick, MD

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.

OBJECTIVES:

Primary

* Compare the percentage of successful remnant ablation at 6-8 months after administration of high- vs low-dose iodine I 131 with vs without recombinant thyroid-stimulating hormone in patients who have undergone total thyroidectomy for differentiated thyroid cancer.

Secondary

* Compare quality of life in patients treated with these regimens.
* Compare locoregional recurrence in patients treated with these regimens.
* Compare distant metastases, survival, and incidence of second primary malignancies in patients treated with these regimens.

OUTLINE: This is a multicenter, factorial, randomized study. Patients are stratified according to treatment center and disease stage (I vs II vs III vs IVA). Patients are randomized to 1 of 4 treatment arms.

Patients receive thyroid hormone replacement therapy (THRT)\* with thyroxine (T4)\*\* or liothyronine sodium (T3). Patients randomized to arm III or IV discontinue THRT 4 weeks (for patients receiving T4) or 2 weeks (for patients receiving T3) prior to remnant ablation.

NOTE: \*Some treatment centers may chose to avoid starting THRT in patients randomized to arm III or IV.

NOTE: \*\*Patients receiving T4 may be switched to T3 for 2 more weeks before discontinuing THRT.

* Arm I: Patients receive recombinant thyroid-stimulating hormone (rTSH) intramuscularly on days 1 and 2 and undergo remnant ablation with low-dose iodine I 131 on day 3.
* Arm II: Patients receive rTSH as in arm I and undergo remnant ablation with high-dose iodine I 131 on day 3.
* Arm III: Patients undergo remnant ablation with low-dose iodine I 131 as in arm I.
* Arm IV: Patients undergo remnant ablation with high-dose iodine I 131 as in arm II.

Quality of life is assessed at baseline, day 3 before remnant ablation, and at 3 months.

After completion of study therapy, patients are followed at 3 months, between 6-8 months, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 468 patients will be accrued for this study.

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

Multicentre Randomised Trial of High Dose Versus Low Dose Radioiodine, With or Without Recombinant Human Thyroid Stimulating Hormone, for Remnant Ablation Following Surgery for Differentiated Thyroid Cancer [HILO]

The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.

Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months

After the 5 year follow up period, patients will be follwed at hospital according to routine practice.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer	NCT00415233	Head and Neck C...	recombinant thy... Radiodine ablat...	16 Years - 80 Years	University College, London
High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer	NCT00415233	Head and Neck C...	recombinant thy... Radiodine ablat...	16 Years - 80 Years	University College, London

Spots Global Cancer Trial Database for radiodine ablation without rhtsh