NCT03579394已完成不适用
CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
ARCAGY/ GINECO GROUP53 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2018年10月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 53
- 主要终点
- Disease Free Survival
研究概览
简要总结
The aim of CHRONO trial is to compare the DFS when surgery is performed after 3 courses of NACT, or after 6 courses of NACT, in a prospective multi institutional randomized setting,considering only patients initially unsuitable for primary surgery.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥18 years.
- •Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, high grade serous or endometrioïd, with the exception of mucinous, clear cell and carcinosarcoma histologies.
- •Performance status < 2 (see Appendix 2).
- •Documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1) stage IIIB-IIIC-IVa unsuitable for complete primary cytoreductive surgery (confirmed by open laparoscopy or by laparotomy [not mandatory for stage IVA]).
- •Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy
- •Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
- •White blood cells (WBC) >3x109/L, absolute neutrophil count (ANC) ≥1,5x109/L, platelets (PLT)
- •≥100x109/L, hemoglobin (Hb) ≥9 g/dL,
- •Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥ 30 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.
- •Signed informed consent obtained prior to any study-specific procedures.
- •Patient affiliated to, or a beneficiary of, a social security category
排除标准
- •Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.
- •Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
- •Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage before 6 months from the enrollment on this study.
- •Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders).
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Interval Debulking Surgery (IDS)
Active Comparator
Complete surgery after 3 courses of neoadjuvant chemotherapy (NACT)
干预措施: Standard IDS (Interval Debulking Surgery) (Procedure)
Retarded Interval Debulking Surgery (IDS)
Experimental
Complete surgery after 6 courses of neoadjuvant chemotherapy (NACT)
干预措施: Retarded IDS (Interval Debulking Surgery) (Procedure)
结局指标
主要结局
Disease Free Survival
时间窗: From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years
Disease free survival (DFS) defined as the time interval between randomization and physical or radiographic evidence of recurrence (local/distant) or second cancer or death (all causes) whichever occur first
次要结局
- CTC-AE version 4.03 adverse events(30 days after last treatment intake, up to 1 year)
- Fagotti laparoscopic score(diagnosis)
- questionnaire OV28(through study completion, up to 2 years)
- Pathological complete response (PCR)(through study completion, up to 2 years)
- Post-operative mortality(up to 5 months)
- Post-operative morbidity(up to 5 months)
- EORTC QLQ-C30(through study completion, up to 2 years)
- Overall survival (OS)(from date of randomisation to death, assessed up to 5 years)
- Time for first subsequent treatment (TFST)(up to 5 years)
研究者
研究点 (53)
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