EUCTR2006-003466-34-NL进行中（未招募）不适用
Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I) - OVHIPEC-I
KI-AV0 个研究点目标入组 280 人开始时间: 2006年10月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.age between 18 and 76 years
- •2. histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid andenocarcinoma.
- •3.in case of pleural effusion cytology should be negative for tumour cells
- •4.In case diagnosis is made based on cytology only (i.e. patients treated by
- •primary chemotherapy) additional criteria apply:
- •?Normal mammogram (< 6 weeks before registration) and
- •?Presence of pelvic mass and
- •?CA 125 > 200 kU/l and
- •?Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is < 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (< 6 weeks before registration) and
- •?Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymphnode metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
- •5.Patients eligible for interval debulking for the following 2 reasons:
- •- Primary debulking surgery not feasible due to tumour extension or general
- •condition (patients treated by primary chemotherapy) or
- •- Incomplete primary debulking with residual disease > 1 cm
- •6.In case of primary chemotherapy:
- •- chemotherapy consists of 3 courses of carboplatin or cisplatin combined
- •- Following 2 cycles of chemotherapy at least a 30% decrease in the sum of largest diameter (LD) of target lesions taking as reference the baseline sum LD (RECIST criteria, see appendix 1)
- •7.In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:
- •- chemotherapy consists of 3 courses of carboplatin or cisplatin combined
- •8.General criteria:
- •- Fit for major surgery, ASA 1 or ASA 2
- •- WHO performance status 0-2
- •- Written informed consent
- •- Laboratory values: serum creatinine < 140 µmol/L; creatinine clearance
- •> 60 ml/min (Cockroft formula) ;
- •white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l
- •9.For quality of life studies:
- •-baseline questionnaires should be filled in before randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •creatinin clearance < 60 ml/min according to Cockcroft-Gault formula
- •-history of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
研究者
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