NCT00548821Unknown3 期
A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 试验地点
- 1
- 主要终点
- The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.
研究概览
简要总结
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stage IB2-IVA , histological proven cervical carcinoma
- •no previous diagnosis of carcinoma
- •no prior history of chemotherapy or radiotherapy
- •ECOG less than or equal to 2
- •Above 21 years old
- •medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy
- •Hemoglobin >10g/dL
- •Adequate hematological, renal and hepatic function according to all of the following laboratory values:
- •Absolute neutrophil count ≥ 1.5 ×109/l
- •Platelets ≥ 100 ×109/l
- •Serum creatinine ≤ 1.5 times upper limit of laboratory normal
- •Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal
- •ASAT(AST) or ALAT(ALT) ≤ 2.5 times upper limit of laboratory normal
- •Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal
排除标准
- •Age below 21
- •Presence of known HIV infection, chronic hepatitis B or hepatitis C infection
- •Psychological, familial, sociological, or geographical condition that would preclude study participation
- •Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)
- •Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
- •Life expectancy < 6 months
- •Patients with insulin dependent diabetes
- •Prior tumor-directed surgery
- •Previous systemic chemotherapy or pelvic radiation therapy
- •As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception
研究组 & 干预措施
2
Experimental
ARM 2: Weekly cisplatin 40mg/m2, concurrent with radiotherapy.
干预措施: Cisplatin (Drug)
1
Experimental
ARM 1: 5-day 3 weekly cisplatin 20mg/m2 for 5 days, concurrent with radiotherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.
次要结局
- The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
研究者
研究点 (1)
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