Study to Examine Decision-Making Criteria for or Against Surgery in Cases of Advanced Uterine Cancer (Endometrial Carcinoma)
- Gender
- Women
- Age
- 18 years and older
- Trial type
- Observational
- Line of therapy
- all
- Phase
- —
What is this trial about?
Cytoreductive surgery (CRS) is a complex surgical procedure performed as part of the treatment for uterine body cancer (endometrial carcinoma) with the goal of completely removing all visible tumor sites. In selected cases, the surgery may offer a survival benefit for patients; however, suitability for this procedure must be carefully assessed. The goal of the STREAM-I study is to identify and evaluate selection criteria for performing CRS in order to predict the potential benefit of the surgery. Women aged 18 and older with advanced or recurrent uterine cancer who underwent CRS between January 2011 and December 2020 are eligible to participate in this study.
Trial flow
Requirements
Diagnosis: endometrial cancer
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: Cytoreductive surgery between 01/2011 and 12/2020 for endometrial carcinoma
Allocation
Einarmige Studie
Treatment
Follow-up
Diagnosis: endometrial cancer
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: Cytoreductive surgery between 01/2011 and 12/2020 for endometrial carcinoma
Einarmige Studie
Detailed description
Uterine body cancer (endometrial carcinoma) is a malignant disease caused by the uncontrolled proliferation of cells in the lining of the uterus. The disease typically occurs in postmenopausal women due to an excess of estrogen. The most common symptom is abnormal vaginal bleeding. The disease can metastasize as it progresses. This means that the cancer cells spread from the uterus to other organs and tissues. If distant metastases are present, the disease is already at an advanced stage and is classified as FIGO Stage 4. In cases of advanced or recurrent (relapse after treatment) uterine cancer, the option of cytoreductive surgery (CRS) should be discussed. CRS is a surgical procedure aimed at reducing the tumor burden to increase the effectiveness of subsequent therapy—such as chemotherapy or immunotherapy. This involves the surgical removal of the uterus, ovaries, fallopian tubes, and any visible tumor foci in the abdominal cavity. If other organs or tissues are affected (e.g., sections of the intestine or the peritoneum), these may also be removed. In selected cases, CRS may offer a survival benefit; however, the decision to proceed with surgery must be carefully evaluated. Criteria for this include, among others, the operability of the tumor, the patient’s general condition, tumor biology, relapse patterns, and prior treatments.
The aim of this retrospective study is to identify and evaluate selection criteria for performing CRS. To this end, clinical characteristics of the patients and biological properties of the tumors (translational features) are examined to predict the successful removal of all visible tumor foci (complete cytoreduction) (primary endpoint). In addition, the aim is to use prognostic factors to identify patients who are likely to benefit from CRS. The findings of this study are also intended to aid in the planning of future prospective studies. As part of the study, a detailed collection of the patients’ clinical data will be conducted. In addition, a molecular biological analysis of the tumor tissue will be performed if it is available (not an inclusion criterion).
Women aged 18 and older with advanced or recurrent uterine cancer who underwent CRS between January 2011 and December 2020 at one of the participating centers are eligible to participate in this study.
Facts
- Disease: Uterine cancer (endometrial carcinoma)
- Cancer characteristics: advanced stage and abdominal metastases (FIGO IV) or recurrence after cytoreductive surgery (CRS); CRS performed between January 2011 and December 2020 at one of the participating centers
- What the study investigates: Identifying and evaluating selection criteria for performing CRS
- Study objective: To identify factors for predicting complete cytoreduction and the individual benefit of CRS for patients
- Study duration: One-time data collection; planned study end date: October 1, 2025
- Study characteristics: Retrospective study, clinical data collection, and examination of tumor tissue
Trial sites
3 trial sites in Germany are listed.
Universitätsklinikum Augsburg
Stenglinstraße 2, 86156 Augsburg
RecruitingUniversitätsklinikum Carl Gustav Carus Dresden
Dresden
RecruitingUniversitätsklinikum Hamburg-Eppendorf
MARTINISTRASSE 52, 20246 Hamburg
Recruiting
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.


