NL-OMON35952已完成3 期
A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer - Surgery for Ovarian Cancer Recurrence (SOCceR)
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 230 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
- 230
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
- •Age >= 18 years
- •First recurrence of histologically or cytologically proven epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer of FIGO stage Ic-IV (FIGO system 1988)
- •First-line treatment consisted of complete or optimal (<= 1 cm) cytoreductive
- •surgery and a minimum of six courses (neo-adjuvant) platinum-taxol based chemotherapy
- •A clinically disease-free interval of at least 6 months after end of first-line
- •treatment, the latter defined as the day the last chemotherapy was administered
- •First recurrence defined as clinical and radiological signs (CT-scan) of
- •recurrence or elevated CA 125 (GCIG criteria) and radiological signs (CT-scan)
- •If there is any doubt whether or not an abnormal finding on CT-scan is
- •recurrent ovarian cancer, confirmation of recurrence with cytological or histological
- •investigation is warranted
- •Good performance status (ECOG 0-1)
- •Ascites < 500 ml (pocket < 8 cm on ultrasound examination)
- •Complete resection seems possible (estimated by a gynecologic oncologist)
- •Adequate hematological, renal, and hepatic function to permit platinum
- •based chemotherapy: WBC > 3.0 x 10*/L, platelets > 100 x 10*/L, serum
- •creatinine < 1.25 x upper normal range (40-90 µmol/L), serum bilirubin < 1.25 x upper normal
- •range (< 17 µmol/L)
- •Informed consent must be obtained and documented according to national
- •and local regulatory requirements and the local rules followed in the institution before
- •randomization
- •Quality of life baseline questionnaires should be filled in after informed
- •consent, preferably before randomization but at least before start treatment
排除标准
- •Participation in interfering trial
- •Non-epithelial or borderline ovarian tumours
- •Other primary malignancy except for carcinoma in situ and basal or
- •squamous cell carcinoma of the skin
- •Patients with platinum-refractory or resistant tumours
- •Intra-abdominal metastatic disease that hampers complete cytoreduction
- •Extra-abdominal metastatic disease that hampers complete cytoreduction
- •Palliative surgery already planned (e.g. bowel surgery)
- •Patients with secondary, third and later recurrence
- •Any disease, medical history or medication not allowing surgery and/or
- •platinum based chemotherapy
- •Prior therapy with respect to recurrence
研究者
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