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Study of External Beam Radiotherapy to Thyroid Carcinoma

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
External Beam Radiotherapy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid Carcinoma, External Beam Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

External Beam Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Full Information

First Posted
July 22, 2010
Last Updated
October 5, 2015
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01173289
Brief Title
Study of External Beam Radiotherapy to Thyroid Carcinoma
Official Title
A Phase II Study of External Beam Radiotherapy for Locoregionally Advanced or Recurrent Differentiated Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Thyroid Carcinoma, External Beam Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Beam Radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy
Intervention Description
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 Outcome Measure Information:
Title
All cause mortality
Time Frame
Two Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tea Hyun Kim, M.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25581596
Citation
Lee EK, Lee YJ, Jung YS, Ryu J, Kim TH, Lee CY, Ryu CH, Kim TS, Kim SK, Chung KW, Kim SS, Kim DY, Kim JY, Cho KH. Postoperative simultaneous integrated boost-intensity modulated radiation therapy for patients with locoregionally advanced papillary thyroid carcinoma: preliminary results of a phase II trial and propensity score analysis. J Clin Endocrinol Metab. 2015 Mar;100(3):1009-17. doi: 10.1210/jc.2014-3242. Epub 2015 Jan 12.
Results Reference
derived

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Study of External Beam Radiotherapy to Thyroid Carcinoma

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