NCT01173289

Study of External Beam Radiotherapy to Thyroid Carcinoma

A Phase II Study of External Beam Radiotherapy for Locoregionally Advanced or Recurrent Differentiated Thyroid Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
RADIATION	External Beam Radiotherapy	Definition of target volume: * Gross tumor volume (GTV) = gross tumor defined with intravenous bolus contrast administration given CT scan * Clinical target volume (CTV) = GTV + included volumes of clinical and suspected subclinical involvement (draining lymph nodes) * Planning target volume (PTV) = CTV + 5-10 mm of lateral, craniocaudal, and anteroposterior margins. Radiation dose and planning * Total dose 65 Gy for gross tumor, 62.4 Gy for microscopic involved area, 58.5 Gy for high risk lymph node area and 52 Gy for elective lymph node area in 26 fractions during 6 weeks * Dose prescription: 90% isodose volume of prescribed dose encompassed PTV * The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the esophagus, lung, contralateral normal thyroid, arytenoids, vocal cord and spinal cord, etc., was calculated.

Timeline

• Start date: 2009-12-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-08-02
• Last updated: 2015-10-07

Locations

1 site across 1 country: South Korea