Modular treatment approach for endometrial cancer with lymphadenectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with intermediate to high-risk endometrial cancer, aiming to reduce locoregional recurrence rates through a novel surgical approach involving Peritoneal Mesometrial Resection (PMMR) and targeted compartmental lymphadenectomy. The study evaluates the feasibility and safety of this method, which has shown promise in previous studies for other cancers. By avoiding unnecessary adjuvant radiotherapy, the study seeks to preserve treatment options for potential recurrences while improving patient outcomes. Participants will be monitored for recurrence rates and overall survival following the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- Histologically proven endometrial carcinoma: endometroid and non-endometroid FIGO stages I-III; Karnofsky-Index ≥ 70; unrestricted operability; Age \>=18 years.
* Completed treatment with according Cohort A, PMMR/targeted compartmental pelvic/paraaortic +/- complete pelvic and paraaortic LNE without adjuvant radiotherapy by the responsible clinic (clinician).

or

* Completed treatment according Cohort B, current clinical practice including adjuvant treatment based on ESMO/ESGO/ESTRO guidelines \[26\] by the responsible clinic (clinician).
* Informed consent of the patient

Exclusion Criteria:

* \- Uterine pure sarcoma
* Distant metastases; sclerodermia, lupus erythematodes, mixed connective tissue disease; secondary malignancy; previous radiotherapy of the pelvis.
* Pregnancy
* Patients with diseases of the connective tissue will be excluded because of unforeseeable (e.g. neurological) symptoms and disorders after surgery.
* Postoperative radiotherapy could be administered with respect to the surgical field in R1 situation or if \>= 5 lymph nodes were involved; in all other situations adjuvant radiotherapy will be an exclusion criterion for participation in the study cohort A. The patient may be offered documentation in analogy but apart from the study protocol.
* Patient who concomitantly participate in other studies may also be included in this study as long as inclusion criteria of this study are met, follow up data will be available and they do not experience an exclusion criterion.

Where it's running

• University Hospital Essen, Department of Gynaecology
  Essen, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Principal investigator: Rainer Kimmig, Prof. — University Hospital, Essen
• Study coordinator: Paul Buderath, Dr.
• Email: paul.buderath@uk-essen.de
• Phone: +492017232442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.