PROfiling Based Endometrial Cancer Adjuvant Therapy (PROBEAT)
Endometrial Cancer Stage I, Endometrial Cancer Stage II
About this trial
This is an interventional treatment trial for Endometrial Cancer Stage I
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
Sites / Locations
- Tongji Hospital, Huazhong University of Science and Technology
- Qilu Hospital of Shandong University
- Women's Hospital School of Medicine Zhejiang UniversityRecruiting
- Peking University Peoples Hospital
- Sun Yat-Sen University Cancer Hospital
- Obstetrics & Gynecology Hospital of Fudan University
- Shanghai First Maternity and Infant Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Molecular profile based treatment
Radiotherapy
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.
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)