EUCTR2010-023081-52-DE进行中（未招募）1 期
A phase II 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 240 人开始时间: 2013年7月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •Target Population
- •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 carcinoma, or undifferentiated carcinoma)
- •Patients with prior therapy:
- •2. 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)
- •3. LNE: minimum 10 pelvic nodes (a minimum of 4 from each side) should be removed. Para-aortic LNE is optional
- •3a. Patients who undergo sentinel lymph node biopsy (SLB) may be included if the surgeon performing the SLB for endometrial cancer. In addition, for each patient, bilateral sentinel node must be identified or a side-specific pelvic lymphadenectomy must be performed if a SLN is not identified in a hemi-pelvis.
- •4. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma
- •5. Surgery performed within 12 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 12 weeks are counted from the last surgery, and in that case the gap between two surgeries should not exceed 8 weeks.
- •Other inclusion criteria
- •6. Patients must give informed consent according to the rules and regulations of the individual participating centres
- •7. Patients have not received any other anticancer therapy other than surgery for endometrial cancer.
- •8. Adjuvant vaginal brachytherapy is permitted in both arm. In chemotherapy arm, VBT should not cause delay in chemotherapy schedule.
- •9. Patients must have WHO performance status of 0-2
- •10. 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 tolerated.
- •11. Life expectancy of at least 12 weeks
- •12. Patients must be fit to receive combination chemotherapy
- •13. Patient’s age >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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Target Disease Exceptions
- •1. 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 patients with second malignanx who has been relapse free for =3 years, or patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin. 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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