Modular treatment approach for endometrial cancer with lymphadenectomy
European Collaborative Multicenter Observational Study: Modular Treatment With PMMR and Targeted Compartmental Pelvic Lymphadenectomy Followed by Therapeutic Pelvic and Paraaortic Lymphadenectomy in Node Positive Disease for Locoregional Control in Endometrial Cancer FIGO Stages I-III
This study is testing a new surgical method for patients with intermediate to high-risk endometrial cancer to see if it can lower the chances of cancer coming back and improve survival without needing extra radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Essen Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Essen, North Rhine-Westphalia) |
| Trial ID | NCT04504006 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically proven endometrial carcinoma at FIGO stages I-III who have completed specific treatment protocols.
Not a fit: Patients with uterine pure sarcoma, distant metastases, or those who have undergone previous pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce locoregional recurrence rates in endometrial cancer patients, leading to improved survival outcomes.
How similar studies have performed: Previous studies have shown promising results with similar surgical approaches in other cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Essen, North Rhine-Westphalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.