CTRI/2021/04/032488招募中未知
Efficacy of low dose lenvatinib as adjuvant therapy to radioiodine in advanced metastatic differentiated thyroid cancer: a randomised control trial
Interdisciplinary Collaborative Intramural Research Project0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
相似试验
招募中
2 期
LENVABLA Lenvatinib in neo-adjuvant and adjuvant therapy for poor-prognosis BCLC A HepatoCellular Carcinoma treated by percutaneous ablation procedure in a curative intent: multicentre pilot therapeutic trial2024-514606-31-00Assistance Publique Hopitaux De Paris50
已完成
1 期
A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary glandJPRN-UMIN000021080Yokohama City University3
已完成
早期 1 期
The Effectiveness of the adjuvant treatment with a compound of sedge plant, saffron and honey to conventional treatment for improvement of cognitive performance of patients with dementiaIRCT2016101030255N1Vice Chancellor for research of Isfahan University of Medical Sciences60
尚未招募
2 期
Evaluation of low dose immunotherapy for lung cancerCTRI/2023/02/050126Indian Council of Medical Research
已完成
2 期
Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II studyColon cancerJPRN-UMIN000006742Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group195