envatinib adjuvant radioiodine therapy in advanced metastatic thyroid cancer
- Conditions
- Health Condition 1: C73- Malignant neoplasm of thyroid gland
- Registration Number
- CTRI/2021/04/032488
- Lead Sponsor
- Interdisciplinary Collaborative Intramural Research Project
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 <= 3 x upper limit
AST/ALT/ALP <= 3 x upper limit
INR <= 1.5 x upper limit
Serum Creatinine <= 1.7 mg/dl
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 ( <1cm) lung metastases and Oligometastatic ( < 5 foci) bone disease.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical and structural responseTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Progression free survivalTimepoint: 2 years