NCT00098878已完成3 期
SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 88
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy.
Secondary
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare overall clinical response rate and CA 125 response in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer*
- •Stage IC-IV disease
- •Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor
- •Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: * Histologic confirmation of a primary source in the ovary is not required.
- •If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:
- •Patient has a pelvis (ovarian) mass AND all of the following:
- •Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease
- •Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization
- •Initial cytoreductive laparotomy or biopsy required within the past 8 weeks
- •Cytoreductive surgery may or may not have been successful during staging laparotomy
- •No mixed mesodermal tumors
- •No borderline ovarian tumors or tumors termed "possibly malignant"
- •No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor
- •Considered unsuitable for or unwilling to receive platinum-taxane combination therapy
- •No concurrent endometrial cancer
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 5 times ULN
- •Creatinine clearance ≥ 30 mL/min
- •Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry
- •Cardiovascular
- •No hypertension
- •No ischemic heart disease
- •No myocardial infarction within the past 6 months
- •No congestive heart failure
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No symptomatic peripheral neuropathy ≥ grade 2
- •No uncontrolled infection
- •No other severe and/or uncontrolled medical condition
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •No other concurrent cytotoxic chemotherapy until progressive disease occurs
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Toxicity
- Quality of life
- Clinical overall response rate and CA125 response
- Overall survival
研究者
研究点 (88)
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