PROfiling Based Endometrial Cancer Adjuvant Therapy
- Conditions
- Endometrial Cancer Stage IIEndometrial Cancer Stage I
- Interventions
- Radiation: Vaginal brachytherapyRadiation: External beam radiotherapyOther: ObservationCombination Product: Chemoradiation therapy
- Registration Number
- NCT05179447
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 590
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiotherapy External beam 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) Molecular profile based treatment Chemoradiation therapy 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. Molecular profile based treatment Vaginal brachytherapy 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. Molecular profile based treatment Observation 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. Radiotherapy Vaginal brachytherapy 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)
- Primary Outcome Measures
Name Time Method Total recurrence 3 years Vaginal, pelvic or distant recurrence as first failure
- Secondary Outcome Measures
Name Time Method Adverse events 3 years, 5 years Treatment-related symptoms according to CTCAE v 5.0
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
Survival 3 years, 5 years Overall survival (all-cause death)
Relapse-free survival 3 years, 5 years Relapse-free survival (survival without relapse)
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
Trial Locations
- Locations (10)
Xiangya Hospital of Central South University
🇨🇳Changsha, China
Sun Yat-Sen University Cancer Hospital
🇨🇳Guangzhou, China
Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, China
Ningbo First Hospital
🇨🇳Ningbo, China
Tongji Hospital, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Women's Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Ningbo Women and Children's Hospital
🇨🇳Ningbo, China
Peking University Peoples Hospital
🇨🇳Beijing, China
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, China