Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- proportion of clinical complete remission
研究概览
简要总结
A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas.
详细描述
The purposes are to assess the safety and efficacy of the treatment starting with NAC and to know whether we can accurately diagnose these advanced carcinomas by imaging studies, cytologic findings and tumor markers without staging laparotomy or laparoscopy. Fifty-six patients with advanced mullerian carcinomas will be recruited to the study. After confirmation of diagnosis by laparoscopic inspection and biopsies, patients undergo 4 cycles of chemotherapy as NAC followed by ICS and additional 4 cycles of postsurgical chemotherapy. The primary endpoint is proportion of clinical complete remission after accomplishment of the protocol treatment and the major secondary endpoint is positive predictive value of diagnosis before laparoscopy regarding tumor origin, histology and stage. Based on the result of this study, we will conduct a phase III study to compare the treatment starting with NAC and primary cytoreductive surgery followed by postsurgical chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage III or IV müllerian carcinoma by prelaparoscopic clinical findings including imaging studies (CT, MRI or ultrasonography)
- •Cytology of ascites, pleural effusions, or fluids obtained by tumor centesis
- •Malignancies of other origins, such as breasts and digestive tract, should be excluded by endoscopy, opaque enema, or ultrasonography when these malignancies are suspected from symptoms, physical examinations or imaging diagnosis.
- •CA125>200U/ml and CEA<20ng/ml.
- •Clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastases, multiple lung, or multiple liver metastases
- •Presence of at least one measurable lesion
- •Previously untreated for these malignancies and no history of treatment with chemotherapy or radiotherapy even for other diseases
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3,
- •Adequate bone marrow, hepatic, renal, cardiac and respiratory functions, and
- •Written informed consent.
排除标准
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- •Pregnant or nursing
- •Severe mental disorders
- •Systemic and continuous use of steroidal drugs
- •Active infections
- •Uncontrolled hypertension
- •Diabetes mellitus, uncontrolled or controlled with insulin
- •History of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration
- •Liver cirrhosis or bleeding tendency contraindicating debulking surgery
- •Intestinal occlusion necessary for surgical treatment
- •Hypersensitivity to alcohol
结局指标
主要结局
proportion of clinical complete remission
次要结局
- positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology
- proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
- PPV of prelaparoscopic diagnosis concerning clinical stage; proportion of the patients diagnosed as stage III or IV by laparoscopic inspection among those diagnosed by prelaparoscopic findings
- PPV of overall prelaparoscopic diagnosis; proportion of the patients diagnosed as stage III or IV müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
- response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy
- proportion of patients who received interval cytoreductive surgery (ICS) among patients whose clinical diagnosis is confirmed by laparoscopy
- progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy
- overall survival among all enrolled patients.
- operative morbidity among all enrolled patients
- adverse events among all enrolled patients, and