Study of Upfront Surgery Versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients with Stage IIIC and IV Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 489
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?
详细描述
OBJECTIVES: Compare the efficacy and safety in patients with AJCC TNM stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery.
OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy.
Patients are followed every 3 months within the first 5 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study within 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Women aged ≥ 18 years.
- •Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration*). Laparoscopic biopsy with pictures is recommended.
- •* If fine needle aspiration showing an adenocarcinoma, patients should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis, and c. serum CA125/CEA ratio>
- •If serum CA125/CEA ratio<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer.
- •ECOG performance status of 0 to
- •ASA score of 1 to
- •Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
- •white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- •serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
- •serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
- •Comply with the study protocol and follow-up.
- •Written informed consent.
排除标准
- •Patients with non-epithelial tumors as well as borderline tumors.
- •Mucinous ovarian cancer.
- •Low grade ovarian cancer.
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- •Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
- •Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
研究组 & 干预措施
Upfront cytoreductive surgery
Upfront cytoreductive surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy.
干预措施: Upfront cytoreductive surgery (Procedure)
Neoadjuvant chemotherapy
neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy.
干预措施: Interval debulking surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: Participants will be followed for at least 5 years after randomization or until death
The time from entry into the study to any cause of death.
次要结局
- Quality of life assessments(Participants will be followed for at least 5 years after randomization or until death)
- Time to second subsequent anticancer therapy (TSST)(Participants will be followed for at least 5 years after randomization or until death)
- The rate of 5-year progression-free survival(Participants will be followed for at least 5 years after randomization or until death)
- Time to first subsequent anticancer therapy (TFST)(Participants will be followed for at least 5 years after randomization or until death)
- Progression-free survival(Participants will be followed for at least 5 years after randomization or until death)
- Post-operative complications(Participants will be followed up to 6 months after randomization)
- The pattern of the first relapse(Participants will be followed for at least 5 years after randomization or until death)
- Outcomes of pulmonary embolism(Participants will be followed for at least 5 years after randomization or until death)
- Accumulated treatment-free survival (TFSa)(Participants will be followed for at least 5 years after randomization or until death)