An interventional study of TSH, T3, T4 and thyroid gland DVH in Head and Neck Cancer, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic
This is a retrospective study with long term follow up to evaluate the incidence, timing and risk factors of radiotherapy induced hypothyroidism in non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy.
For any patient, fixation was done by a thermoplastic mask. CT scan was done at 3mm thickness for the head and neck region. CT images were transferred to the planning system. Three-dimensional conformal RT, intensity-modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT) was created. All patients were irradiated with once-daily fractionation at 1.8-2.0 Gy/d with 6-MV photon beams for five days a week. The gross target volume (GTV) was treated with a dose of 70Gy and the lymphatic site (CTV) and areas of high risk microscopic disease (CTV) including lymph nose levels received a radiation dose ranging from 54-66 Gy according to its risk. PTV is a circumferential margin of 5mm around CTV.
Thyroid function parameters:
The patient's serum T4, T3 and TSH levels, were measured during follow up. Clinical hypothyroidism is defined as the increase in TSH above 5.0mIu/ml with a decrease in free thyroxine levels (free T4) in the serum while elevated TSH with normal free T4 levels was labeled as subclinical hypothyroidism .As per institutional values, the normal values intervals of T4 level (7- 25 PMOL/L), T3( 1.5-7 PMOL/L),TSH (0.2-5 mIu/L).
The median time to onset of hypothyroidism was defined as the time interval between completion of radiotherapy and first abnormal recorded T3/T4/TSH value.
For all treated patients, thyroid gland was delineated and by reviewing the DVH, the V45, V50, V55, V60, V65 and V70 which means the volume of the thyroid gland receiving 45 Gy, 50 Gy, 55Gy, 60 Gy and 70 Gy respectively.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 101 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
measuring thyroid functions and DVH parameters of thyroid gland
The the incidence of hypothyroidism
Measuring the thyroid function tests
Time frame: 8 months
The risk factors of hypothyroidism
Defining the risk factors of hypothyroidism
Time frame: 8 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Cairo University