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New treatment option for Endometrial Cancer Stage I
Official title PROfiling Based Endometrial Cancer Adjuvant Therapy
ClinicalTrials.gov ID: NCT05179447
What this study is testing
What is Chemoradiation therapy?
Chemoradiation therapy is an investigational medicine, being studied as a potential treatment for endometrial cancer stage i.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping...
- Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one...
- World Health Organization (WHO)-performance status 0-2
- Written informed consent
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- World Health Organization (WHO)-performance status 0-2
- Written informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Jinan, Shandong, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Changsha, China
- Guangzhou, China
- Ningbo, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Jinan, Shandong, China; Hangzhou, Zhejiang, China; Beijing, China; Changsha, China; Guangzhou, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.