Endometrial Cancer Stage I, Endometrial Cancer Stage II
Conditions
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.
Interventions
RADIATIONVaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy. For brachytherapy administered after completion of External beam radiotherapy (EBRT): Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
RADIATIONExternal beam radiotherapy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
OTHERObservation
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
COMBINATION_PRODUCTChemoradiation therapy
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Sponsors
Tongji Hospital
Qilu Hospital of Shandong University
Obstetrics & Gynecology Hospital of Fudan University
Sun Yat-sen University
Peking University People's Hospital
Shanghai First Maternity and Infant Hospital
Xiangya Hospital of Central South University
Anhui Provincial Cancer Hospital
Ningbo Women & Children's Hospital
Ningbo No. 1 Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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 3. World Health Organization (WHO)-performance status 0-2 4. Written informed consent
Exclusion criteria
1. With residual disease 2. Any other stage and type of endometrial carcinoma 3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma 4. Uterine sarcoma (including carcinosarcoma) 5. Previous malignancy (except for non-melanomatous skin cancer) 6. Previous pelvic radiotherapy 7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total recurrence | 3 years | Vaginal, pelvic or distant recurrence as first failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival | 3 years, 5 years | Relapse-free survival (survival without relapse) |
| Survival | 3 years, 5 years | Overall survival (all-cause death) |
| Health-related cancer-specific quality of life | 3 years, 5 years | Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on Quality of Life Core Questionnaire-30 functioning scales, general quality of life and general cancer symptoms, quite a bit/very much vs no or mild symptoms |
| Endometrial cancer related health care costs | 3 years, 5 years | All hospital based health care costs used with primary treatment or during followup for treatment of adverse events and/or treatment for relapse |
| Adverse events | 3 years, 5 years | Treatment-related symptoms according to CTCAE v 5.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recurrence (vaginal and total) per risk profile | 3 years, 5 years | Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms |
Countries
China
Contacts
Primary ContactXinyu Wang, MD
Backup ContactYang Li, PhD
Outcome results
None listed