Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Gansu Cancer Hospital; General Hospital of Ningxia Medical University; Peking University First Hospital; The 940th Hospital of Joint Logistics Support Force，PLA.; The Affiliated Hospital of Inner Mongolia Medical University; The Second Affiliated Hospital of Dalian Medical University; The second hospital Affiliated by Jilin University; Third Affiliated Hospital of Xinjiang Medical University; Xiangya Hospital of Central South University; Xijing Hospital, Air Force Medical University of PLA

Criteria

Inclusion Criteria:

1. Women aged 18-75.

2. Patients with newly histologically confirmed Endometrioid adenocarcinoma.

3. ECOG score 0-2

4. Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy

5. Patients with FIGO staging(2009 edition) I or II and meet one of the following conditions:

1. Stage IA G1-2 with massive LVSI+ or age ≥ 60 years

2. Stage IA G3, regardless of LVSI status

3. Stage IB G1-3, regardless of LVSI status

4. Stage II, regardless of tumor grade and LVSI status

6. Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment.

Exclusion Criteria:

1. Not FIGO stage I-II.

2. Residual tumor or positive margin.

3. Mixed carcinoma, sarcoma or carcinosarcoma

4. Previous history of malignant tumor

5. Previous history of pelvic radiotherapy

6. The interval between surgery and radiotherapy is more than 12 weeks.

7. With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy