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]
试验速览
- 阶段
- 3 期
- 入组人数
- 438
- 试验地点
- 25
- 主要终点
- Proportion of patients with successful remnant ablation at 6-9 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- 未提供
研究组 & 干预措施
1.1Gbq with rhTSH
Patients receive 1.1GBq dose of radioactive iodine and rhTSH
干预措施: recombinant thyroid-stimulating hormone (Biological)
3.2 GBq with rhTSH
Patients receive 3.2GBq dose of radioactive idodine and rhTSH
干预措施: recombinant thyroid-stimulating hormone (Biological)
1.1GBq without rhTSH
Patients only receive 1.1GBq dose of radioactive iodine and no rhTSH
干预措施: Radiodine ablation without rhTSH (Radiation)
3.2GBq without rhTSH
Patients only receive 3.2GBq dose of radioactive iodine and no rhTSH
干预措施: Radiodine ablation without rhTSH (Radiation)
结局指标
主要结局
Proportion of patients with successful remnant ablation at 6-9 months
时间窗: 6-9 months
The percentage of patients who have a successful remnant ablation at 6-9 months after radioiodine administration.
次要结局
- 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)