ACTRN12605000561684招募中2 期
A phase II trial to evaluate the effect on progression-free survival of adjuvant chemo-radiation followed by chemotherapy with carboplatin and paclitaxel for patients with newly diagnosed endometrial carcinoma at high-risk of relapse
Peter MacCallum Cancer Centre0 个研究点目标入组 40 人开始时间: 2005年9月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 ot stated（—）
- 性别
- Female
入选标准
- •Patients must have newly diagnosed, histologically confirmed endometrial carcinoma, and have undergone a total abdominal hysterectomy and bilateral salpingo-oophorectomy with or without a dissection of pelvic and/or para-aortic nodes. It is also recommended that patients will have undergone an omentectomy and had peritoneal washings taken. In addition, patients must be either:A. Patients with documented involvement of pelvic and/or para-aortic nodes by histology (FIGO stage IIIc) or post-operative PET, CT or PET/CTORB. Patients who have not undergone a complete lymphadenectomy, who have negative sampled nodes or unknown nodal status and have high-risk disease as defined by:a) FIGO stage Ic or IIb with : aggressive non-endometroid histology (serous papillary or clear cell type comprising 10% of the endometrial tumour) ORb) FIGO stage IIb with : grade 3 histologyc) Any FIGO stage III disease excluding those defined as stage III only by positive peritoneal cytologyPatients must not have received any prior chemotherapy for another malignancy. Patients who have been treated for other malignancies must not have received prior pelvic or abdominal radiotherapy, and any prior radiotherapy must have been to less than 15% of the bone marrow bearing areasECOG performance status less than 2Life expectancy of greater than 6 months.Patients must have normal organ and marrow function as defined below:- absolute neutrophil count >1,500- platelets > 100,000- total bilirubin < 1.25 X upper limit of normal - AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal.- estimated GFR > 50 ml/minPatient has given written informed consent.
排除标准
- •Patients with other invasive malignancies, with the exception of treated non-melanoma skin cancer, in the last 5 yearsPatients receiving any other therapeutic investigational agents Patients who are receiving concurrent treatment with any other anti-cancer therapyPatients who have commenced any post-surgical anti-cancer treatment for endometrial cancerEvidence of distant metastasesHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin Symptomatic peripheral neuropathy greater than or equal to grade 2.Serious illness of medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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