Study of External Beam Radiotherapy to Thyroid Carcinoma
The primary objective of this study is to estimate the 5 year locoregional control rate after External Beam Radiotherapy (EBRT) in the patient with locally advanced differentiated thyroid cancer. In a prior retrospective trial for this same group of patients, the 5 year locoregional control rate was 85% in EBRT group and 70% in no EBRT group. For the total number of patients to detect a minimum of 20% improvement in 5 year locoregional control rate with 80% of statistical power and the 5% significance level, the table for sample size planning given by Makuch and Simon was chosen. Forty-three patients are required for this regimen to regard as worthy of further investigation. Considering 15% follow up loss, 50 eligible patients will be enrolled.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of External Beam Radiotherapy for Locoregionally Advanced or Recurrent Differentiated Thyroid Carcinoma|
- All cause mortality [ Time Frame: Two Years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: External Beam Radiotherapy||
Radiation: External Beam Radiotherapy
Definition of target volume:
Radiation dose and planning
The standard approaches to the treatment of differentiated thyroid cancer include surgical resection, radioactive iodine treatment, and thyroid-stimulating hormone suppression. The role of external beam radiotherapy (EBRT), however, remains controversial.
The purpose of this phase II study is to evaluate the impact of EBRT on the locoregional control in locoregionally advanced or recurrent differentiated thyroid cancer patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173289
|Contact: Tea Hyun Kim, M.D.||+ 82 31 920 firstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center, Korea||Recruiting|
|Goyang-si, Gyeonggi-do, Korea, Republic of|
|Contact: Tae Hyun Kim, M.D.|