Health Condition 1: C73- Malignant neoplasm of thyroid gland
Conditions
Interventions
Intervention1: Low dose lenvatinib (10mg per day) along with standard radioiodine (RAI) therapy: RAI Dose - 200 mCi (if lung metastases - 150 mCI)
Frequency - Once
Route of administration - oral Dura
Sponsors
Interdisciplinary Collaborative Intramural Research Project
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven DTC post total thyroidectomy. 2. RAI avid distant metastases on post therapy 131-I whole body scan (WBS). 3. Adequate end organ function 28 days prior to study registration as given by Hemoglobin >= 10 g/dL Leucocytes >= 3000/mcL Platelets >= 1,00,000/mcL Total Bilirubin AST/ALT/ALP INR Serum Creatinine
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women. 2. Anti thyroglobulin (TgAb) levels > 125 IU/ml 3. Patients with Thyroglobulin Elevated Negative Iodine Scintigraphy (TENIS) syndrome. 4. Patients with subcentimetric nodular ( 5. Eastern Cooperative Oncology Group (ECOG) performance status 4. 6. Patients who had received cumulative 131-I therapeutic activity of >= 1 Curie. 7. Prior therapy with TKIs. 8. Active hemoptysis (Bright red blood > 1/2 tea spoon) or other uncontrolled bleeding 14 days prior to study registration. 9. Any thromboembolic events 12 months prior to study registration. 10. 24 hour urine protein > 1 g (done only if > 1+ proteinuria on urine dipstick testing). 11. QTc interval > 480 ms on ECG 12. Refusal to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical and structural responseTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactChandra Teja Reddy Singareddy
All India Institute of Medical Sciences
Outcome results
None listed