ACTRN12606000167561终止3 期
A phase III feasibility study to evaluate the difference in average weekly haemoglobin concentrations between experimental and control groups and the impact of red cell concentrate transfusion of maintaining haemoglobin levels above 120g/l versus above 100g/l in anaemic patients with carcinoma of the cervix receiving concurrent cisplatin and radiation therapy.
Investigator initiated trial (name of investigator is Dr Michelle Grogan) coordinated by the University of Sydney.0 个研究点目标入组 100 人开始时间: 2006年5月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
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 ot stated（—）
- 性别
- Female
入选标准
- •1.Primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO Stage IB2 (equal to or greater than 4 cm diameter), II, III-B or IV-A;2.Haemoglobin level at randomization less than or equal to 125 g/l;3.No radiographic or pathologic evidence of para-aortic lymphadenopathy;4.Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation;5.Adequate bone marrow function: ANC equal to or greater than 1.5 x 10 to the power of 9 /L; platelets equal to or greater than 100 x 10to the power of 9 /L;6.Adequate renal function with serum creatinine lesss than or equal to 1.5 times the institutional upper limit of normal;7.Approved informed consent;8.Geographically accessible and suitable for long-term follow-up.
排除标准
- •1.Patients who have not been or cannot be adequately clinically staged;2.Patients with cancers of the uterine cervix other than squamous cell,adenosquamous, or adenocarcinoma;3.Patients with lower one-third vaginal involvement;4.Patients with disease outside the pelvis or with known intraperitoneal disease;5.Patients who for any reason have had previously been treated with pelvic radiation or have any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease, pregnancy);6.Patients who have had a previous or concomitant invasive cancer other than basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;7.Patients who have medical contraindications to chemotherapy, in particular cisplatin;8.Patients who have had a previous hysterectomy or carcinoma of the cervical stump; 9.Patients with a medical or psychosocial problem which, in the investigators opinion, would interfere with treatment or follow-up.
研究者
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