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Study of External Beam Radiotherapy to Thyroid Carcinoma

This study is currently recruiting participants.
Verified April 2012 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Tae Hyeon Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01173289
First received: July 22, 2010
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Thyroid Cancer
 Radiation: External Beam Radiotherapy
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: External Beam Radiotherapy 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173289

Contacts
Contact: Tea Hyun Kim, M.D. + 82 31 920 1725 krog@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Tae Hyun Kim, M.D.            
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Tae Hyeon Kim, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01173289     History of Changes
Other Study ID Numbers: NCCCTS-09-436
Study First Received: July 22, 2010
Last Updated: April 25, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Thyroid Carcinoma
External Beam Radiotherapy

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013