EUCTR2010-023081-52-GB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5月23日最近更新:
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
入选标准
- •Target Population
- •1.Only node-negative patients are eligible: Histological confirmed endometrial carci-noma 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, squamous cell carcinoma, carcinosarcoma or undifferentiated carcinoma)
- •Prior therapy
- •2.Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oopherectomy (BSO) and pelvic lymphadenectomy (LNE).
- •3.LNE: minimum 10 pelvic nodes (4 from each side) should be removed. Para-aortic LNE is optional.
- •3.aPatients who undergo sentinel lymph node biopsy (SLB) may be included if the surgeon performing the SLB has performed at least 20 cases of SLB for endome-trial 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 iden-tified in a hemi-pelvis.
- •4.Omentectomy strongly recommended in clear cell, serous or undifferentiated car-cinoma.
- •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 sur-gery, 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 en-dometrial cancer.
- •8.Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery.
- •9.Patients must have a 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 up-per normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or calculated according to Cockroft-Gault, Jeliffe or Wright formula). 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 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
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 another anticancer clinical trial.
- •Other exclusion criteria
- •5.Previous or concurrent malignant disease except for patients with second malig-nancy 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.
- •6.Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
- •7.Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
- •8.Whatever reasons which interferes with an adequate follow-up
- •9.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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