Health Condition 1: E078- Other specified disorders of thyroid
Conditions
Interventions
Intervention1: Radioiodine ablation: 30 mCi or 1.1 GBq activity will be administered orally.
Control Intervention1: Radioiodine ablation: 100-120 mCi 3.7 GBq activity will be administered orally.
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 2. Histopathologically proven well differentiated DTC satisfying following criteria a. T1-T3a with cN1 AJCC 8th edition b. Clinically detectable lymph node metastasis c. Metastatic lymph node size less than 3 cm
Exclusion criteria
Exclusion criteria: 1. High risk histopathology- tall cell, columnar cell, solid variant, hobnel variant, poorly differentiated, widely invasive follicular carcinoma more than 4 lympho-vascular emboli 2. Gross extrathyroidal extension of tumour 3. Incomplete surgery R1, R2 resection, tumour spill during surgery 4. Any lymphnode size more than or equal to 3 cm 5. Lymphnodes with gross extranodal extension 6. Lymph-node micro metastasis detected in histopathology in the absence of any clinically detectable nodes 7. Distant metastasis indicated by cross sectional imaging or whole body scan or by abnormally high post-operative thyroglobulin 8. Presence of any other malignancy 9.Pregnancy, lactation or nursing mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint Patients with no evidence of structural disease, Defined as the percentage of patients without persistent or recurrent structural disease at the end of five year follow up. It will include patients with excellent response, indeterminate response and biochemical incomplete response, but are without structural disease at the end of follow up. Timepoint: Follow up schedule- follow up 1- 6 months to 1 year from date of treatment follow up 2- 2 years plus minus 2 months from the date of treatment follow up 3- 3 years plus minus 2 months from the date of treatment follow up 4- 4 years plus minus 2 months from the date of treatment follow up 5- 5 years plus minus 2 months from the date of treatment follow up 6- 6 years plus minus 2 months from the date of treatment follow up 7- 7 years plus minus 2 months from the date of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects will be assessed with the help of a clinical questionnaire at inclusion, at the time of discharge, at 6 months after radio iodine therapy, at 3 years, 5 years and 7 years from the date of treatment.Timepoint: Follow up period of 5 to 7 years;Disease free survival Defined as the time duration from the date of randomization to the date of structural recurrence or death due to thyroid cancer.Timepoint: Follow up period of 5 to 7 years;Fear of cancer recurrence will be evaluated with Fear of Cancer Recurrence - 7 questionnaire at inclusion, at the time of discharge, and respectively at 1 year, 3 year, 5 year and 7 year from the date of treatment.Timepoint: Follow up period of 5 to 7 years;Percentage of patients without persistent or recurrent structural disease with or without rise in Triglycerides at the end of 7 year follow up.Timepoint: Follow up period of 5 to 7 years;Rate of biochemical incomplete response at the end of 5 year and 7 yearTimepoint: Follow up period of 5 to 7 years;Rate of biochemical recurrence in the absence of structural disease, after initial excellent or indeterminate response, at the end of 5 year and 7 yearTimepoint: Follow up period of 5 to 7 years;Rate of patients undergoing re surgery at the end of 5 year and 7 yearTimepoint: Follow up period of 5 to 7 years;Rate of patients undergoing retreatment with radio iodine at the end of 5 year and 7 yearsTimepoint: Follow up period of 5 to 7 years;Success rate of ablation of thyroid remnantTimepoint: Follow up period of 5 to 7 years | — |
Countries
India
Contacts
Public ContactDr Venkatesh Rangarajan
Tata Memorial Centre
Outcome results
None listed