PROfiling Based Endometrial Cancer Adjuvant Therapy

Launched by WOMEN'S HOSPITAL SCHOOL OF MEDICINE ZHEJIANG UNIVERSITY · Dec 16, 2021

Keywords

ClinConnect Summary

The PROfiling Based Endometrial Cancer Adjuvant Therapy trial is studying how to better decide on treatment options for women with a specific type of endometrial cancer called endometrioid adenocarcinoma, especially for those with higher risks. In this study, researchers are comparing different treatment methods—like no additional therapy, vaginal brachytherapy (a form of internal radiation), external beam radiation (a common type of radiation therapy), or a combination of chemotherapy and radiation—based on the unique characteristics of the cancer found in each participant. This trial aims to see if using genetic and other detailed information about the cancer can lead to more personalized and effective treatment decisions.

To be eligible for this trial, participants need to have had surgery for stage I or II endometrial cancer and must meet specific health criteria, such as having no remaining cancer after surgery. Women aged 65 to 74 are being recruited for this trial. Those who join will receive careful monitoring and be part of a group that helps shape the future of endometrial cancer treatment. It’s important to know that this study is looking for women who meet certain criteria, and not all patients with endometrial cancer will qualify.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• 2. 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
• • 3. World Health Organization (WHO)-performance status 0-2
• • 4. Written informed consent
• Exclusion Criteria:
• • 1. With residual disease
• • 2. Any other stage and type of endometrial carcinoma
• • 3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
• • 4. Uterine sarcoma (including carcinosarcoma)
• • 5. Previous malignancy (except for non-melanomatous skin cancer)
• • 6. Previous pelvic radiotherapy
• • 7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks