NL-OMON38240已完成3 期
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
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 240 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 adenocarcinoma.
- •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 first 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 first 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 no progression should occur
- •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 randomisation
排除标准
- •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
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