Brief Title
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
Official Title
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
Brief Summary
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 shows a high
level of accuracy in precluding nodal involvement in endometrial cancer. Thus, unnecessary
complete lymphadenectomy may be avoided in patients with proven node negative disease.
However, this procedure is aimed on diagnostic and not therapeutic goals. Nevertheless,
therapeutically it fits well in the surgical concept of compartmental surgery indicating the
peripheral border of therapeutic surgical approach. This leads to the concept to resect the
embryologically determined tissue of risk en bloc together with the "sentinel nodes" of the
draining lymph compartment (module I). In case of positive node extended therapeutic pelvic
and paraaortic lymphadenectomy (module II) may be indicated. This should now be evaluated in
a European collaborative observational trial. The surgical arm (cohort A) will include
Patients who have received surgical treatment (module I) and in case of positive nodes or
enhanced risk for isolated positive paraaortic nodes (module II) and don't want to receive
adjuvant radiation therapy; in intermediate/high risk situations, however, adjuvant
chemotherapy should be offered to these patients. For patients with high-risk carcinomas who
do not want to be treated with the modular concept, the option of receiving systematic
lymphadenectomy during primary surgery will be given. Patients who prefer to be treated
according current clinical practice will be asked to participate in cohort B to be observed
as concomitant control and will be treated according to current clinical practice based on
the European ESMO/ESGO/ESTRO-Guidelines. Primary endpoint will be loco-regional recurrence
and recurrence free survival. Follow up is planned for 5 years following date of first
surgery (module I).
Study Type
Observational [Patient Registry]
Primary Outcome
Progression Free Survival
Secondary Outcome
Overall survival
Condition
Endometrial Cancer
Intervention
Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)
Study Arms / Comparison Groups
Cohort A
Description: PMMR + TCL, followed by systematic lymphadenectomy in node positive patients.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
500
Start Date
October 10, 2017
Completion Date
January 1, 2030
Primary Completion Date
January 1, 2025
Eligibility 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rainer Kimmig, Prof., +492017232442, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04504006
Organization ID
PMMR
Responsible Party
Sponsor-Investigator
Study Sponsor
Dr. Paul Buderath
Study Sponsor
Rainer Kimmig, Prof., Principal Investigator, University Hospital, Essen
Verification Date
August 2020