Study of External Beam Radiotherapy to Thyroid Carcinoma

NCT01173289 | Completed Phase 2

• 1 other identifier: NCCCTS-09-436
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

Thyroid Carcinoma; External Beam Radiotherapy

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Two Years

Study Arms (1)

External Beam Radiotherapy

EXPERIMENTAL

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.

Radiation: External Beam Radiotherapy

Interventions

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.

External Beam Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25581596 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Tea Hyun Kim, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: August 2, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

KR (1)