Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 10
- 主要终点
- Total recurrence
研究概览
简要总结
This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.
详细描述
Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, Lymph-Vascular Space Invasion (LVSI) and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) have become available which are strongly related to outcomes and risk of cancer spread. Based on 2022 National Comprehensive Cancer Network (NCCN) guideline and the ongoing "Portec-4a" trial, this randomized trial using integrated genomic-pathologic classification to assign adjuvant treatment for women with stage I-II high-intermediate and intermediate risk endometrioid adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection, with or without para-aortic lymphadenectomy, oophorectomy
- •Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage and grade:
- •Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II
- •World Health Organization (WHO)-performance status 0-2
- •Written informed consent
排除标准
- •With residual disease
- •Any other stage and type of endometrial carcinoma
- •Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
- •Uterine sarcoma (including carcinosarcoma)
- •Previous malignancy (except for non-melanomatous skin cancer)
- •Previous pelvic radiotherapy
- •Expected interval between the operation and start of radiotherapy exceeding 8 weeks
研究组 & 干预措施
Molecular profile based treatment
Determination of the integrated genomic-pathologic profile to determine adjuvant treatment: observation for POLE-mutated profile; vaginal brachytherapy for intermediate profile; chemo-radiotherapy for p53-abnormal profile.
干预措施: Vaginal brachytherapy (Radiation)
Molecular profile based treatment
Determination of the integrated genomic-pathologic profile to determine adjuvant treatment: observation for POLE-mutated profile; vaginal brachytherapy for intermediate profile; chemo-radiotherapy for p53-abnormal profile.
干预措施: Observation (Other)
Molecular profile based treatment
Determination of the integrated genomic-pathologic profile to determine adjuvant treatment: observation for POLE-mutated profile; vaginal brachytherapy for intermediate profile; chemo-radiotherapy for p53-abnormal profile.
干预措施: Chemoradiation therapy (Combination Product)
Radiotherapy
Adjuvant vaginal brachytherapy for intermediate risk (stage I A with G3 or stage I B with G1-2) and external beam pelvic radiotherapy for high-intermediate risk (stage I B with G3, or stage II) (standard treatment)
干预措施: Vaginal brachytherapy (Radiation)
Radiotherapy
Adjuvant vaginal brachytherapy for intermediate risk (stage I A with G3 or stage I B with G1-2) and external beam pelvic radiotherapy for high-intermediate risk (stage I B with G3, or stage II) (standard treatment)
干预措施: External beam radiotherapy (Radiation)
结局指标
主要结局
Total recurrence
时间窗: 3 years
Vaginal, pelvic or distant recurrence as first failure
次要结局
- Adverse events(3 years, 5 years)
- Health-related cancer-specific quality of life(3 years, 5 years)
- Survival(3 years, 5 years)
- Relapse-free survival(3 years, 5 years)
- Endometrial cancer related health care costs(3 years, 5 years)
研究者
Wang Xinyu
Clinical Professor
Women's Hospital School Of Medicine Zhejiang University