NCT00415233

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
438

participants targeted

Target at P75+ for phase_3 head-and-neck-cancer

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3 head-and-neck-cancer

Geographic Reach
1 country

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
14.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 19, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

December 20, 2006

Last Update Submit

December 12, 2023

Conditions

Head and Neck Cancer

Keywords

stage I follicular thyroid cancerstage I papillary thyroid cancerstage II follicular thyroid cancerstage II papillary thyroid cancerstage III follicular thyroid cancerstage III papillary thyroid cancerstage IV follicular thyroid cancerstage IV papillary thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with successful remnant ablation at 6-9 months

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

    6-9 months

Secondary Outcomes (5)

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

    Baseline to 3 months

  • Locoregional recurrence

    During and post treatment

  • Distant metastases

    Baseline to 5 years after randomisation of final patient

  • Survival

    Until patient death

  • Incidence of second primary malignancy

    Baseline to 5 years after last patient is randomised

Study Arms (4)

1.1Gbq with rhTSH

EXPERIMENTAL

Patients receive 1.1GBq dose of radioactive iodine and rhTSH

Biological: recombinant thyroid-stimulating hormone

3.2 GBq with rhTSH

EXPERIMENTAL

Patients receive 3.2GBq dose of radioactive idodine and rhTSH

Biological: recombinant thyroid-stimulating hormone

1.1GBq without rhTSH

EXPERIMENTAL

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

Radiation: Radiodine ablation without rhTSH

3.2GBq without rhTSH

EXPERIMENTAL

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

Radiation: Radiodine ablation without rhTSH

Interventions

recombinant thyroid-stimulating hormoneBIOLOGICAL

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

1.1Gbq with rhTSH3.2 GBq with rhTSH
Radiodine ablation without rhTSHRADIATION

Patients in this group do not receive rhTSH pre ablation.

1.1GBq without rhTSH3.2GBq without rhTSH

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (25)

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Castle Hill Hospital

Cottingham, England, HU16 5JQ, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

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

Guildford, England, GU2 7XX, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

University Hospital of North Staffordshire

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

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Wales, LL 18 5UJ, United Kingdom

Location

Related Publications (2)

  • 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. doi: 10.1056/NEJMoa1109589.

    PMID: 22551128RESULT

  • Dehbi 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: 30501974DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, Papillary

Interventions

ThyrotropinThyrotropin Alfa

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinoma, PapillaryThyroid NeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ujjal K. Mallick, MD

    Newcastle-upon-Tyne Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2011

Study Completion

July 1, 2025

Last Updated

December 19, 2023

Record last verified: 2023-11

Locations

GB(25)