EUCTR2004-002429-37-SE进行中（未招募）不适用
A randomized trial of adjuvant treatment with radiation plus chemotherapy versus radiation alone in high-risk endometrial carcinoma NSGO-EC-9501 Amendment 2.
ordic Society for Gynecologic Oncology0 个研究点目标入组 400 人开始时间: 2004年10月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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. Patients must have histologically proven endometrial cancer, of one of the fol-lowing types:
- •- FIGO grade 3 or WHO poorly differentiated endometrioid adenocarcinoma (adenosquamous adenocarcinoma included) with infiltration ?50% of the myometrial thickness a.
- •- >10% of the tumor consisting of serous carcinoma regardless of grade and differentiation
- •- >10% of the tumor consisting of clear cell carcinoma regardless of grade and differentiation
- •- Undifferentiated or anaplastic carcinoma
- •2. Patients must have an endometrial cancer in one of the following FIGO 1988 sur-gical stages b.
- •- stage I b
- •- stage II without macroscopic tumor involvement of the cervix at preopera-tive examination (occult stage II)
- •- stage IIIA only because of positive peritoneal fluid cytology
- •- stage IIIC only because of positive pelvic lymph nodes, but without post-operative macroscopic residual tumor.
- •3. Patients must be fit to receive combination chemotherapy.
- •4. Patients must have a WHO performance status of 0-2 and have an adequate bone marrow, renal, hepatic and pulmonary function.
- •5. Patient’s age >18 years
- •6. Patients must give informed consent according to the rules and regulations of the individual participating centers.
- •a Swedish centers can also include patients with two of the three risk factors: grade, myome-trial infiltration, or non-diploidy.
- •b Lymphadenectomy is not mandatory
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any macroscopic postoperative residual tumor.
- •2. Spread of disease on the surface or outside the uterus, except to macroscopically radically excised pelvic lymph nodes or positive peritoneal fluid cytology.
- •3. Macroscopic tumor involvement of the cervix at preoperative examination.
- •4. Para-aortic lymph node involvement.
- •5. Squamous carcinoma or small cell carcinoma with neuroendocrine differentiation.
- •6. Preoperative irradiation.
- •7. Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •8. Active infection or other serious underlying medical condition, which might pre-vent the patient from receiving treatment or to be followed
- •9. Uncontrolled or potentially active site of pelvic infection (e.g. fistula or ab-scesses).
- •10. Inadequate bone marrow, liver, or kidney function (WBC <3.5x109/L, neutrophils < 1.5x109/L, platelets <100x109/L S-creatinine > upper normal value, total S-bilirubin > 2 x upper normal value, estimated GFR <50 ml/min according to Cock-roft-Gault or Jeliffe for patients who will be treated with cisplatin.
- •11. Previous extensive abdominal surgery or other condition that might give a sub-stantial increase in the risk for complications from the radiation treatment or che-motherapy.
- •12. Whatever reasons which interferes with an adequate follow-up.
- •13. Longer interval than 7 weeks between surgery and randomization.
研究者
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