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

Last updated: December 12, 2023
Sponsor: University College, London
Overall Status: Active - Not Recruiting

Phase

3

Condition

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Nasopharyngeal Cancer

Treatment

recombinant thyroid-stimulating hormone

Radiodine ablation without rhTSH

Clinical Study ID

NCT00415233
UCL/05/83
ISRCTN56078540
CRUK-HILO-BRD/05/83
2005-003687-37
EU-20665
CTA-20363/0217/001/0001
  • Ages 16-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 438
Treatment Group(s): 2
Primary Treatment: recombinant thyroid-stimulating hormone
Phase: 3
Study Start date:
November 01, 2006
Estimated Completion Date:
July 31, 2025

Study Description

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.

Connect with a study center

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England BN2 5BE
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, England CB2 2QQ
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, England CT1 3NG
    United Kingdom

    Site Not Available

  • Castle Hill Hospital

    Cottingham, England HU16 5JQ
    United Kingdom

    Site Not Available

  • Derbyshire Royal Infirmary

    Derby, England DE1 2QY
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital

    Exeter, England EX2 5DW
    United Kingdom

    Site Not Available

  • Gloucestershire Royal Hospital

    Gloucester, England GL1 3NN
    United Kingdom

    Site Not Available

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England GU2 7XX
    United Kingdom

    Site Not Available

  • Ipswich Hospital

    Ipswich, England IP4 5PD
    United Kingdom

    Site Not Available

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England LS9 7TF
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Guy's Hospital

    London, England SE1 9RT
    United Kingdom

    Site Not Available

  • Royal Marsden - London

    London, England SW3 6JJ
    United Kingdom

    Site Not Available

  • Maidstone Hospital

    Maidstone, England ME16 9QQ
    United Kingdom

    Site Not Available

  • Christie Hospital

    Manchester, England M20 4BX
    United Kingdom

    Site Not Available

  • James Cook University Hospital

    Middlesbrough, England TS4 3BW
    United Kingdom

    Site Not Available

  • Newcastle Upon Tyne Hospitals NHS Trust

    Newcastle-Upon-Tyne, England NE4 6BE
    United Kingdom

    Site Not Available

  • Northampton General Hospital

    Northampton, England NN1 5BD
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England HA6 2RN
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, England NR4 7UY
    United Kingdom

    Site Not Available

  • Dorset Cancer Centre

    Poole Dorset, England BH15 2JB
    United Kingdom

    Site Not Available

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England S10 2SJ
    United Kingdom

    Site Not Available

  • University Hospital of North Staffordshire

    Stoke-On-Trent, England ST4 7LN
    United Kingdom

    Site Not Available

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales CF14 2TL
    United Kingdom

    Site Not Available

  • Glan Clwyd Hospital

    Rhyl, Wales LL 18 5UJ
    United Kingdom

    Site Not Available

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales LL 18 5UJ
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.