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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to best decide on additional treatments for women with early-stage endometrial cancer, which is a type of cancer that starts in the lining of the uterus. Researchers want to compare two methods: one that uses detailed genetic information (molecular classification) and another that uses traditional methods based on risk factors. The goal is to find the safest and most effective way to provide additional therapy, known as adjuvant radiotherapy, after surgery.

To be eligible for this trial, participants need to be women aged 18 to 75 who have been recently diagnosed with a specific type of endometrial cancer called endometrioid adenocarcinoma. They should have undergone surgery to remove the uterus and possibly other surrounding tissues. Participants will also need to be in good enough health to handle the treatment. If chosen for the study, participants can expect close monitoring and guidance as they receive their treatment, helping to ensure that their care is tailored to their specific situation. It's important to note that this study is not yet recruiting participants, so it will start at a later date.

Gender

FEMALE

Eligibility 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