Clinical trial · Interventional
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]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiodine ablation without rhTSH | Radiation | — | UNRESOLVED |
| recombinant thyroid-stimulating hormone | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1.1Gbq with rhTSH
- description
- Patients receive 1.1GBq dose of radioactive iodine and rhTSH
- interventionNames
- Biological: recombinant thyroid-stimulating hormone
- type
- EXPERIMENTAL
- label
- 3.2 GBq with rhTSH
- description
- Patients receive 3.2GBq dose of radioactive idodine and rhTSH
- interventionNames
- Biological: recombinant thyroid-stimulating hormone
- type
- EXPERIMENTAL
- label
- 1.1GBq without rhTSH
- description
- Patients only receive 1.1GBq dose of radioactive iodine and no rhTSH
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (2)
- RESULTMallick 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. doi: 10.1056/NEJMoa1109589. PMID 22551128
- DERIVEDDehbi HM, Mallick U, Wadsley J, Newbold K, Harmer C, Hackshaw A. Recurrence after low-dose radioiodine ablation and recombinant human thyroid-stimulating hormone for differentiated thyroid cancer (HiLo): long-term results of an open-label, non-inferiority randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Jan;7(1):44-51. doi: 10.1016/S2213-8587(18)30306-1. Epub 2018 Nov 27. PMID 30501974