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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

Recruitingn/aAges 18 Years - anyFemaleDr. Paul Buderath
NCT04504006 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Intermediate/high risk endometrial cancer shows locoregional recurrence rates up to 20%. Also in so called low-risk disease 5-10% incidence of nodal metastasis is reported. Although adjuvant radiotherapy may reduce these recurrences there has been no survival benefit. To avoid toxicity of irradiation and preserve the full potential of radiotherapy for salvage treatment of recurrences surgery should avoid locoregional recurrence. According to the concept of ontogenetically based compartmental surgery it may be suggested that this may be achieved by PMMR and therapeutic LNE as it has been already shown for TMMR in cervical cancer and TME in rectal cancer. First, monocentric data have shown feasibility and safety of this approach and are promising with respect to reduce locoregional recurrence rate significantly. On parallel it has also been convincingly shown that sentinel node detection s

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📋 Eligibility rules (as published)
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.
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What it tests

  • Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)
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Where

1 site
University Hospital Essen, Department of Gynaecology
Essen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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