Status:
COMPLETED
Study of External Beam Radiotherapy to Thyroid Carcinoma
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01173289
Start Date
December 1 2009
End Date
August 1 2015
Last Update
October 7 2015
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea