NCT00330915已完成2 期
A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Feasibility of Pemetrexed Prior to Surgery
研究概览
简要总结
The purpose of this study is to help answer the following research questions:
If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •no prior therapy for rectal cancer
- •pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
- •adequate organ function
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
- •signed informed consent
- •at least 18 years of age
- •surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.
排除标准
- •concurrent administration of any other anti-tumor therapy
- •treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •serious concomitant systemic disorders
- •previously completed or withdrawn from this study
- •pregnant or breast-feeding
- •second primary malignancy
- •history of significant neurological or mental disorder, including seizures or dementia
- •inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
- •presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry
- •inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
研究组 & 干预措施
A
Experimental
干预措施: pemetrexed (Drug)
结局指标
主要结局
Feasibility of Pemetrexed Prior to Surgery
时间窗: 3 cycles (21-day cycles)
Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.
次要结局
- Pathological Complete Response (pCR)(surgery following 3 cycles (21-day cycles) of chemotherapy)
- Number of Participants With Complete Tumor Resection(surgery following 3 cycles (21-day cycles) of chemotherapy)
- Number of Participants Receiving Sphincter Saving Surgery(surgery following 3 cycles (21-day cycles) of chemotherapy)
研究者
研究点 (1)
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