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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pathologically confirmed differentiated thyroid cancer
Patient with locally advanced tumor (T4a, tumor of any size extending beyond the thyroid capsule to invade subcutaneous soft tissues, larynx, trachea, esophagus, or recurrent laryngeal nerve or T4b, tumor invades prevertebral fascia or encases carotid artery or mediastinal vessels or N1b, unilateral, bilateral, or contralateral cervical or mediastinal lymph node positive), or locoregionally recurrent tumor
All patients must have radiographically assessable disease
No previous irradiation to the planned field
Age of ≥ 18 years
Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; creatinine ≤ 3.0 mg/dL
Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
Signed informed consent form prior to study entry

Exclusion criteria

Patient with anaplastic carcinoma (focal anaplastic change associate with differentiated thyroid cancer is not excluded)
Age of <18 years
Previous history of RT adjacent to planned field
Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
Pregnant or breast feeding status
Previous history of uncontrolled other malignancies within 2 years

Treatment and study plan

External Beam Radiotherapy

Radiation

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.

Primary outcomes

All cause mortality

Time frame: Two Years

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Aug 2, 2010
Registry last updated: Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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