EUCTR2010-023081-52-NL进行中（未招募）不适用
A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer. - ENGOT-EN2-DGCG
Danish Gynaecological Cancer Group0 个研究点目标入组 678 人开始时间: 2015年9月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 678
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Only node-negative patients are eligible: Histological confirmed endometrial carcinoma with no macroscopic remaining tumour after
- •primary surgery and lymph-node negative disease, with one of the following postoperative FIGO 2009 stage and grade:
- •a.Stage I grade 3 endometrioid adenocarcinoma
- •b.Stage II endometrioid adenocarcinoma
- •c.Stage I and II type 2 histology (clear cell, serous, or squamous cell
- •carci-noma, or undifferentiated carcinoma)
- •2. Patients with prior therapy:
- •a. Patients have undergone hysterectomy (total abdominal hysterectomy (TAH), radical hysterectomy, laparoscopic or robotic hysterectomy) and
- •& bilateral salpingo-oopherectomy (BSO) (or RH) and+ pelvic lymphadenectomy (LNE) within the past 10 weeks.
- •b. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional
- •c. Omentectomy strongly recommended in type 2 disease (clear cell, serous, squamous cell carcinoma or undifferentiated carcinoma)
- •d. Surgery performed within 10 weeks of randomization. If the dates for hys-terectomy and lymph node dissection are different, 10 weeks are
- •counted from the last surgery, and in that case the gap between two surgeries should not exceed 8 weeks.
- •3. Other inclusion criteria
- •a. Patients must give informed consent according to the rules and regulations of the individual participating centres
- •b. Patients have not received any other anticancer therapy other than surgery.
- •c. Adjuvant vaginal brachytherapy is not recommended, though permitted in both arms. In chemotherapy arm, VBT timing of VBT should
- •not cause delay in chemotherapy delivery.
- •d. Patients must have WHO performance status of 0-2
- •e. Patients must have an adequate bone-marrow, renal and hepatic function (WBC =3.0x109/L, neutrophils =1.5x109/L, platelets =
- •100x109/L, total S-bilirubin <2 x upper normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or calculated
- •according to Cockroft-Gault or Jeliffe). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are
- •f. Life expectancy of at least 12 weeks
- •g. Patients must be fit to receive combination chemotherapy
- •h. Patient's age > or = 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •Target Disease Exceptions
- •1. Carcinosarcoma, Sarcomas or small cell carcinoma with
- •neuroendocrine differentiation.
- •Prohibited Treatments and/or Therapies
- •2. External Beam Radiotherapy
- •3. Concurrent cancer therapy
- •4. Concurrent treatment with an anticancer investigational agent or
- •participation in anotheranticancer clinical trial
- •Other exclusion criteria
- •5. Previous or concurrent malignant disease except for curatively treated
- •carcinoma in situ of the cervix or basal cell carcinoma of the skin
- •6. Active infection or other serious underlying medical condition, which
- •might prevent the patient from receiving treatment or to be followed.
- •7 . Whatever reasons which interferes with an adequate follow-up
- •8. Patients who are breast feeding must stop breast feeding before
- •enrolment in the trial and must not do so during whole trial period,
- •otherwise these patients are non-eligible
研究者
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