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result sql = Feasibility of a randomized trial on adjuvant radio-iodine therapy in differentiated thyroid cancer.
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result sql = BACKGROUND : Justification for adjuvant radio-iodine (I-131) therapy in differentiated thyroid cancer (DTC) is purely based on retrospective data. This is true for ablative therapy and even more so for high-dosage adjuvant schedules. Randomized trials on the latter application are considered impossible due to anticipated formidable sample sizes required in a disease with an overall excellent prognosis like DTC.
OBJECTIVE : To develop and validate a model that could stratify for risk of recurrence, rather than survival, as is usually done in prognostic indices, and secondly, to use this model to estimate the sample size required for a randomized trial.
DESIGN, PATIENTS AND RESULTS : From databases of three large Dutch centres, we identified 342 consecutive patients without known residual DTC after (near-) total thyroidectomy. Using Cox proportional hazards analysis, a model was validated that clearly distinguished risk categories of recurrence using commonly available baseline variables. The model included age, N stage at presentation and T stage in papillary carcinoma. According to this stratification, a subset of patients at substantial risk for relapse (30-40%) was identified. They could be eligible for a trial assessing the impact of high-dose adjuvant I-131 on recurrence rates. Assuming a clinically relevant effect of 30% reduction of relapses, 290 patients would have to be entered in either arm (alpha 0.05, power 80%).
CONCLUSION : We conclude that even though a randomized trial on this issue will be difficult to design and conduct, sample size is not the main problem.
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result sql = Feasibility of a randomized trial on adjuvant radio-iodine therapy in differentiated thyroid cancer.
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char = i;code = 105
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char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
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char = a;code = 97
char = i;code = 105
char = n;code = 110
char = ;code = 32
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result sql = BACKGROUND : Justification for adjuvant radio-iodine (I-131) therapy in differentiated thyroid cancer (DTC) is purely based on retrospective data. This is true for ablative therapy and even more so for high-dosage adjuvant schedules. Randomized trials on the latter application are considered impossible due to anticipated formidable sample sizes required in a disease with an overall excellent prognosis like DTC.
OBJECTIVE : To develop and validate a model that could stratify for risk of recurrence, rather than survival, as is usually done in prognostic indices, and secondly, to use this model to estimate the sample size required for a randomized trial.
DESIGN, PATIENTS AND RESULTS : From databases of three large Dutch centres, we identified 342 consecutive patients without known residual DTC after (near-) total thyroidectomy. Using Cox proportional hazards analysis, a model was validated that clearly distinguished risk categories of recurrence using commonly available baseline variables. The model included age, N stage at presentation and T stage in papillary carcinoma. According to this stratification, a subset of patients at substantial risk for relapse (30-40%) was identified. They could be eligible for a trial assessing the impact of high-dose adjuvant I-131 on recurrence rates. Assuming a clinically relevant effect of 30% reduction of relapses, 290 patients would have to be entered in either arm (alpha 0.05, power 80%).
CONCLUSION : We conclude that even though a randomized trial on this issue will be difficult to design and conduct, sample size is not the main problem.
Publication: Clin. Endocrinol. (Oxf) 2003 Apr ;58(4)::451-5.
Publication Date: 2003 Apr
Study Author(s): Dragoiescu, C;Hoekstra, O S;Kuik, D J;Lips, P;Plaizier, M A B D;Rodrigus, P T R;Huijsmans, D A K C J M;Ribot, J G;Kuijpens, J;Coebergh, J W W;Teule, G J J;
Institution: Department of Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
Shortcut link to this study:
Publication Date: 2003 Apr
Study Author(s): Dragoiescu, C;Hoekstra, O S;Kuik, D J;Lips, P;Plaizier, M A B D;Rodrigus, P T R;Huijsmans, D A K C J M;Ribot, J G;Kuijpens, J;Coebergh, J W W;Teule, G J J;
Institution: Department of Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
Shortcut link to this study:
BACKGROUND : Justification for adjuvant radio-iodine (I-131) therapy in differentiated thyroid cancer (DTC) is purely based on retrospective data. This is true for ablative therapy and even more so for high-dosage adjuvant schedules. Randomized trials on the latter application are considered impossible due to anticipated formidable sample sizes required in a disease with an overall excellent prognosis like DTC.
OBJECTIVE : To develop and validate a model that could stratify for risk of recurrence, rather than survival, as is usually done in prognostic indices, and secondly, to use this model to estimate the sample size required for a randomized trial.
DESIGN, PATIENTS AND RESULTS : From databases of three large Dutch centres, we identified 342 consecutive patients without known residual DTC after (near-) total thyroidectomy. Using Cox proportional hazards analysis, a model was validated that clearly distinguished risk categories of recurrence using commonly available baseline variables. The model included age, N stage at presentation and T stage in papillary carcinoma. According to this stratification, a subset of patients at substantial risk for relapse (30-40%) was identified. They could be eligible for a trial assessing the impact of high-dose adjuvant I-131 on recurrence rates. Assuming a clinically relevant effect of 30% reduction of relapses, 290 patients would have to be entered in either arm (alpha 0.05, power 80%).
CONCLUSION : We conclude that even though a randomized trial on this issue will be difficult to design and conduct, sample size is not the main problem.
OBJECTIVE : To develop and validate a model that could stratify for risk of recurrence, rather than survival, as is usually done in prognostic indices, and secondly, to use this model to estimate the sample size required for a randomized trial.
DESIGN, PATIENTS AND RESULTS : From databases of three large Dutch centres, we identified 342 consecutive patients without known residual DTC after (near-) total thyroidectomy. Using Cox proportional hazards analysis, a model was validated that clearly distinguished risk categories of recurrence using commonly available baseline variables. The model included age, N stage at presentation and T stage in papillary carcinoma. According to this stratification, a subset of patients at substantial risk for relapse (30-40%) was identified. They could be eligible for a trial assessing the impact of high-dose adjuvant I-131 on recurrence rates. Assuming a clinically relevant effect of 30% reduction of relapses, 290 patients would have to be entered in either arm (alpha 0.05, power 80%).
CONCLUSION : We conclude that even though a randomized trial on this issue will be difficult to design and conduct, sample size is not the main problem.
PMID: 12641628
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Related Concepts
How is this determined?
The order of these related concepts is determined by a statistical analysis of the scientific literature. Highest-frequency concepts appear first.
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