Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

All cause mortality

Outcome Time Frame:

Two Years

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

NCCCTS-09-436

NCT ID:

NCT01173289

Start Date:

December 2009

Completion Date:

November 2012

Related Keywords:

  • Thyroid Cancer
  • Thyroid Carcinoma
  • External Beam Radiotherapy
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location