EUCTR2010-023081-52-BE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: 2012年9月24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 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.a Patients 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
- 另有 3 项未显示
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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