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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00415233
First received: December 20, 2006
Last updated: June 20, 2012
Last verified: June 2012
History of Changes

December 20, 2006
June 20, 2012
November 2006
June 2011   (final data collection date for primary outcome measure)
Proportion of patients with successful remnant ablation at 6-9 months [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.
  • Compare proportion of patients with successful remnant ablation at 6-8 months among those given high- vs low-dose iodine I 131
  • Relative risk of having a successful remnant ablation
  • Compare proportion of patients with successful remnant ablation at 6-8 months among those given recombinant thyroid-stimulating hormone (rTSH) vs no rTSH
Complete list of historical versions of study NCT00415233 on ClinicalTrials.gov Archive Site
  • Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    Quality of life as measured by the SF-36 questionnaire at baseline, the day of ablation, and at 3 months
  • Locoregional recurrence [ Time Frame: During and post treatment ] [ Designated as safety issue: No ]
  • Distant metastases [ Time Frame: Baseline to 5 years after randomisation of final patient ] [ Designated as safety issue: No ]
    After the 5 year follow up period, patients will be follwed at hospital according to routine practice.
  • Survival [ Time Frame: Until patient death ] [ Designated as safety issue: No ]
  • Incidence of second primary malignancy [ Time Frame: Baseline to 5 years after last patient is randomised ] [ Designated as safety issue: No ]
    After the 5 year follow up period, patients will be follwed at hospital according to routine practice.
  • Compare 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
Not Provided
Not Provided
 
Iodine I 131 With or Without Thyroid-Stimulating Hormone in Treating Patients Who Have Undergone Surgery for 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]

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Head and Neck Cancer
  • 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.
  • Experimental: 1.1Gbq with rhTSH
    Patients receive 1.1GBq dose of radioactive iodine and rhTSH
    Intervention: Biological: recombinant thyroid-stimulating hormone
  • Experimental: 3.2 GBq with rhTSH
    Patients receive 3.2GBq dose of radioactive idodine and rhTSH
    Intervention: Biological: recombinant thyroid-stimulating hormone
  • Experimental: 1.1GBq without rhTSH
    Patients only receive 1.1GBq dose of radioactive iodine and no rhTSH
    Intervention: Radiation: Radiodine ablation without rhTSH
  • Experimental: 3.2GBq without rhTSH
    Patients only receive 3.2GBq dose of radioactive iodine and no rhTSH
    Intervention: Radiation: Radiodine ablation without rhTSH
Mallick U, Harmer C, Yap B, Wadsley J, Clarke S, Moss L, Nicol A, Clark PM, Farnell K, McCready R, Smellie J, Franklyn JA, John R, Nutting CM, Newbold K, Lemon C, Gerrard G, Abdel-Hamid A, Hardman J, Macias E, Roques T, Whitaker S, Vijayan R, Alvarez P, Beare S, Forsyth S, Kadalayil L, Hackshaw A. Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer. N Engl J Med. 2012 May 3;366(18):1674-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
438
June 2015
June 2011   (final data collection date for primary outcome measure)

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 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)
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00415233
CDR0000522490, CRUK-HILO-BRD/05/83, ISRCTN56078540, EU-20665, CTA-20363/0217/001/0001, EUDRACT-2005-003687-37
Yes
University College, London
University College, London
Not Provided
Study Chair: Ujjal K. Mallick, MD Newcastle-upon-Tyne Hospitals NHS Trust
University College, London
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP