NL-OMON54837招募中3 期
Randomised Phase Ill Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer: PORTEC-4a - PORTEC-4a
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Adult patients with histologically confirmed endometrioid type endometrial
- •carcinoma, FIGO 2009 stage I, with one of the following combinations of stage,
- •grade, age, and LVSI:
- •1. Stage IA, grade 3 (any age, with or without LVSI)
- •2. Stage IB, grade 1 or 2 and age >60 years
- •3. Stage IB, grade 1-2 with documented LVSI
- •4. Stage IB, grade 3 without LVSI
- •5. Stage II (microscopic), grade 1
- •Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral
- •Salpingo-Oophorectomy (TH-BSO) with or without pelvic lymphadenectomy, lymph
- •node sampling or sentinel node procedure (not recommended, but permitted)
- •WHO-performance status 0-2
- •Written informed consent
排除标准
- •The following criteria exclude the patient from enrolment in this trial:
- •1. Any other stage and type of endometrial. carcinoma
- •2. Non-endometrioid endometrial carcinoma, such as serous or clear cell
- •carcinoma (at least 10% in mixed types), or undifferentiated or neuroendocrine
- •3. Uterine sarcoma (including carcinosarcoma)
- •4. Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
- •5. Previous pelvic radiotherapy
- •6. Verwacht interval between the operation and start of radiotherapy exceeding
研究者
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