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Thyroid CancerPhase 2NCT01173289

Study of External Beam Radiotherapy to Thyroid Carcinoma

A Phase 2 study testing External Beam Radiotherapy in people with Thyroid Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
External Beam Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteSouth Korea
Study dates
Dec 2009to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center, Korea

    Goyang-si, Gyeonggi-do

Other trials in South Korea

About this study

Official title: A Phase II Study of External Beam Radiotherapy for Locoregionally Advanced or Recurrent Differentiated 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.

Read the 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
Being tested
External Beam Radiotherapy
Keywords
Thyroid Carcinoma, External Beam Radiotherapy
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Beam RadiotherapyRadiation

    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.
Study groups in NCT01173289
Study groupRoleWhat they receive
External Beam RadiotherapyExperimentalDefinition 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.
Receives: Radiation: External Beam Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: Two Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01173289
Sponsor's protocol ID
NCCCTS-09-436
Status last verified
Oct 2015
First submitted
22 Jul 2010
Last updated
7 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25581596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing External Beam Radiotherapy in people with Thyroid Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: Two Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01173289, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.

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