Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer Stage I
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Enrollment
- 590
- Locations
- 10
- Primary Endpoint
- Total recurrence
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Wang Xinyu
Clinical Professor
Women's Hospital School Of Medicine Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Total recurrence
Time Frame: 3 years
Vaginal, pelvic or distant recurrence as first failure
Secondary Outcomes
- 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)