Open Labeled Phase II Study Evaluating Efficacy and Safety of Chemotherapy With Gemcitabine - Oxaliplatin Combination for Advanced Refractory Thyroid Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options are limited in this setting. Molecular targeted therapies have recently been developed for progressive disease and demonstrated clinical activity, especially with anti-angiogenic agents.
For patients with contra-indication to these agents or in case of progression or toxicity during treatment, chemotherapy is usually proposed but this strategy has not been validated by prospective data.
The investigators propose to conduct an open single arm phase 2 study to evaluate response rate according to RECIST 1.1 with GEMOX regimen (gemcitabine - oxaliplatin combination) for advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic agents or in case of contra-indication to anti-angiogenic therapy.
详细描述
The aim is to study efficacy of chemotherapy with gemcitabine - oxaliplatin combination for advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic agents or in case of contra-indication to anti-angiogenic therapy.
For refractory thyroid cancer patients, in case of contra-indication to molecular targeted therapies or in case of progression or toxicity during treatment, alternative treatments are urgently needed.
Our study could precise if cytotoxic agents should remain a treatment option for refractory thyroid cancer after molecular targeted therapies or in case of contra-indication.
Numerous clinical trials are proposed to evaluate various molecular targeted therapies for refractory thyroid cancer, either conducted by institutional or industrial promoters. In contrast, chemotherapy trials are lacking. As generics are actually available for gemcitabine and oxaliplatin, no industrial support can be expected and prospective evaluation a chemotherapy regimen need to be conducted by an institutional promoter ("Assistance Publique - Hôpitaux de Paris"), supported by many French expert teams through the rare tumor network ""TUTHYREF"".
GEMOX regimen will be administrated intravenously every two weeks in ambulatory setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
gemcitabine -oxaliplatine combination
干预措施: gemcitabine -oxaliplatine combination (Drug)
结局指标
主要结局
overall response rate
时间窗: 4 months
overall response rate measured (complete and partial responses) by CT-scan according to RECIST criteria v1.1
次要结局
- number of adverse events and serious adverse events (AE) according to CTCAE v4.03(up to 12 month)
- Early metabolic response rate on 18F-FDG-TEP/CT(2 months)
- Disease control rate(4 months)
- Time to progression(up to 36 months)
- Progression free survival(up to 36 months)
- Overall survival(up to 36 months)
- Quality of life(at day 1(week 1, i.e first cycle) and repeated every 28 days (i.e at W5, W9, W13, W17) during chemotherapy and every 3 months until 12 months)