ACTRN12609000141246已完成3 期
MATES: A phase III trial of anti-angiogenic agent Thalidomide in patients with unresectable malignant mesothelioma who are not progressing after first line therapy compared to no additional treatment after chemotherapy to assess the effectiveness of Thalidomide using time to progression.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologically or cytologically proven diagnosis of malignant mesothelioma of the pleura or peritoneum.
- •- Presence of at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = 20mm with conventional techniques or as > or = 10 mm with spiral computed tomography (CT) scan.
- •- Chemotherapy, containing the antifolate (pemetrexed), is required with at least stabilisation or response (Partial response (PR) or Complete Response (CR)) of the disease with a tleast 4 courses of therapy.
- •- Women of childbearing age must have a negative pregnancy test or must have adequate contraception during the study and for 3 months after cessation of thalidomide.
- •-Prior surgery or radiotherapy is allowed as long as there was evidence of progression.
- •- All cytotoxic therapies should be stopped at least 2 weeks before randomisation.
- •- Palliative radiotherapy to painful lesions or to prevent the development of metastases along biopsy tracks is allowed.
- •- Performance status according to Eastern Cooperative Oncology Group- World Health Organisation (ECOG WHO) < or = 2 (After palliative measures like pleural drainage)
排除标准
- •-Pre-existing = grade II sensory neuropathy.
- •-Severe cardiac, pulmonary, metabolic or other serious co-morbid condiotions.
- •- Pregnant or lactating women are excluded.
- •- Life expectancy of < 3 months.
- •- Uncontrolled infections.
- •- Prior treatment with thalidomide.
- •- A period of > or = 6 weeks after the end of chemotherapy treatment.
研究者
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