Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Iodine I 131 With or Without Thyroid-Stimulating Hormone in Treating Patients Who Have Undergone Surgery for Thyroid Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 16 to 80 Other CRUK-HILO-BRD/05/83 ISRCTN56078540, EU-20665, CTA-20363/0217/001/0001, EUDRACT-2005-003687-37, NCT00415233

Objectives

Primary

1. 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

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

Entry Criteria

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

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 3 months since prior contrast CT scan
• No prior iodine I 131 or iodine I 123 pre-ablation scan
• No prior treatment for thyroid cancer (except surgery)

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

Expected Enrollment

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

Outcomes

Proportion of patients with successful remnant ablation at 6-8 months
Relative risk of having a successful remnant ablation

Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months
Locoregional recurrence
Distant metastases
Survival
Incidence of second primary malignancy

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

Trial Contact Information

Trial Lead Organizations

Cancer Research UK and University College London Cancer Trials Centre

Ujjal Mallick, MD, Protocol chair		Ph: 44-191-256-3571

United Kingdom
England
	Cambridge
	Addenbrooke's Hospital
		Sarah Jefferies	Ph:  44-1223-245-151
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Stephen Whitaker, MD	Ph:  44-1483-571-122
	Ipswich
	Ipswich Hospital
		Christopher Scrase, MD	Ph:  44-147-370-4177
	London
	Guy's Hospital
		Sue Clarke, MD	Ph:  44-20-7188-7188
	Royal Marsden - London
		Chris Nutting	Ph:  44-20-7808-2586
			Email: Chris.Nutting@rmh.nthames.nhs.uk
	Manchester
	Christie Hospital
		Beng Yap, MD	Ph:  44-845-226-3000
	Newcastle-Upon-Tyne
	Newcastle Upon Tyne Hospitals NHS Trust
		Ujjal Mallick, MD	Ph:  44-191-256-3571
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Catherine Lemon, MD	Ph:  44-1923-826-111
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Jonathan Wadsley	Ph:  44-114-226-5000
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Laura Moss	Ph:  44-29-2031-6205

Registry Information
Official Title		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]
Trial Start Date		2006-11-08
Trial Completion Date		2009-11-08 (estimated)
Registered in ClinicalTrials.gov		NCT00415233
Date Submitted to PDQ		2006-11-14
Information Last Verified		2008-12-21

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