Differentiated thyroid cancer (DTC)
Conditions
Interventions
Trade Name: Thyrogen
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Thyrotropin alfa
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 16-80 years 2.Patients who have undergone one or two-stage total thyroidectomy with or without lymph node dissection. 3.Patients with histological confirmation of differentiated thyroid cancer (including Hurthle cell carcinoma) who require radioiodine ablation. 4.Patient with tumour stage pT1-T3; NX, N0 or N1 5.WHO performance status 0-2 (self caring) 6.All known tumour resected (R0) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Aggressive variants including tall cell, insular, poorly differentiated, diffuse sclerosing and widely invasive subtypes; anaplastic and medullary carcinoma. 2.Patients who have a contrast CT scan up to 3 months before ablation. 3.Patients for whom recombinant human TSH requirement is mandatory. 4.Patients who have severe co-morbid conditions (eg unstable angina, recent heart attack or stroke, severe labile hypertension, dementia, on dialysis, with tracheostomy needing care, learning difficulties and anybody who may not be able to comply with radiation protection issues or need frequent nursing/medical supervision which puts staff at risk of unacceptable radiation exposure) 5.Pregnant women or women who are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of the trial are: (i) to determine whether a low dose of radioactive iodine (1.1 GBq) is as effective as the commonly used high dose (3.7GBq) in ablating any remaining thyroid tissue after surgery (ii) to determine whether taking recombinant human thyroid stimulating hormone (rhTSH) has no adverse effect on radioactive iodine ablation of the thyroid remnant compared to the current practice of withdrawing thyroid hormone 2-4 weeks before radioiodine ablation.;Secondary Objective: The secondary objectives are: ·to determine whether a low dose of radioactive iodine is equally effective on large and small thyroid remnants. ·to determine whether the low and high doses of radioactive iodine give equivalent disease free survival rates. ·to compare quality of life at the time of ablation in patients given rhTSH and those on hormone withdrawal;Primary end point(s): The percentage of patients who have a successful remnant ablation at 6-8 months after radioiodine administration. | — |
Countries
United Kingdom
Outcome results
None listed