Status:
UNKNOWN
High Dose vs Low Dose I 131 +/- rhTSH for Differentiated Thyroid Cancer
Lead Sponsor:
University College, London
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
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 i...
Detailed 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 hormo...
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)
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT00415233
Start Date
November 1 2006
End Date
July 1 2025
Last Update
December 19 2023
Active Locations (25)
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1
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
2
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
3
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
4
Castle Hill Hospital
Cottingham, England, United Kingdom, HU16 5JQ