The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.
Women aged 18-75.
Patients with newly histologically confirmed Endometrioid adenocarcinoma.
ECOG score 0-2
Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy
Not FIGO stage I-II.
Residual tumor or positive margin.
Mixed carcinoma, sarcoma or carcinosarcoma
Previous history of malignant tumor
Parallel
Vaginal brachytherapy
RadiationHigh-dose rate vaginal brachytherapy (VBT) was delivered with a vaginal cylinder.For VBT administered alone, the dose is recommended: 3 fractions of 7 Gy or 5 fractions of 6 Gy or 6 fractions of 5 Gy. For VBT administered after completion of EBRT: 2-3 fractions of 4-6 Gy.
Pelvic external beam radiotherapy
RadiationEBRT was delivered to the pelvic area using a total dose of 45-50.4Gy in 25-28 fractions over 5-6 weeks with the intensity-modulated radiotherapy (IMRT) technique, three-dimensional conformal radiotherapy (3D-CRT) modality
Observation
Other interventionNo radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.
Chemotherapy
DrugIntravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.
Loco-regional recurrence (LRR)
Loco-regional recurrence (LRR) is defined as the first recurrence in the vagina or pelvic cavity during follow-up, which was confirmed by imaging examination or biopsy pathology.
Failure free survival(FFS)
FFS is defined as the time from randomization to recurrence,distant metastasis or death from any cause,whichever is first.
Overall survical(OS)
Overall survival is calculated from randomization to death from any cause.
Cumulative vaginal recurrence
Recurrence in the vaginal area during follow-up
Cumulative pelvic recurrence
Recurrence in the pelvic area, including the vagina, during follow-up
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
The First Affiliated Hospital of Air Force Medicial University
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
Second Hospital of Jilin University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Third Affiliated Hospital of Xinjiang Medical University
Collaborator
Peking University First Hospital
Collaborator
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
Xiangya Hospital of Central South University
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
