Endometrial CancerPMMRNCT04504006
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
An observational study of Endometrial Cancer, run by Dr. Paul Buderath at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2017to 1 Jan 2030
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with the primary diagnosis of histologically proven endometrial carcinoma: endometroid and non-endometroid FIGO stages I-III; Karnofsky-Index ≥ 70; unrestricted operability; Age >=18 years.
Who may be able to join
- - 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
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen, Department of Gynaecology
Essen, North Rhine-Westphalia, 45122
Paul Buderath, Dr., +492017232442, paul.buderath@uk-essen.de
Rainer Kimmig, Prof., +492017232441, rainer.kimmig@uk-essen.de
About this study
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).
- Conditions
- Endometrial Cancer
- Being tested
- Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)Procedure or surgery
Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | PMMR + TCL, followed by systematic lymphadenectomy in node positive patients. Receives: Procedure: Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL) | |
| Cohort B | Therapy according to actual guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time to recurrence or progression
Measured: 36 months
Intra- and postoperative complications, incidence of lymph oedema
Measured: 36 months
Secondary outcomes (4)
Overall survival
Time to death of any cause
Measured: 36 months
Rate of locoregional relapse and rate of distant metastases at 3 years.
Measured: 36 months
Pelvic organ functioning
Therapy-induced morbidity on bladder/urethra, rectum/bowel, vagina/vulva, assessed by the LENT-SOMA scoring system
Measured: 36 months
QoL
Quality of life by EORTC-QLQ-C30 questionnaire at 12 and 24 months after surgery.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start10 Oct 2017
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Dr. Paul Buderath
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Paul Buderath, University Hospital, Essen
- Investigators
- Rainer Kimmig, Prof., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504006
- Sponsor's protocol ID
- PMMR
- Acronym
- PMMR
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04504006
- Acronym / sponsor ID
- PMMR / PMMR
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr. Paul BuderathUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)PMMR + TCL, followed by systematic lymphadenectomy in node positive patients. |
| Cohort B | – | –Therapy according to actual guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with the primary diagnosis of histologically proven endometrial carcinoma: endometroid and non-endometroid FIGO stages I-III; Karnofsky-Index ≥ 70; unrestricted operability; Age >=18 years.
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (6 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL) | Procedure or surgery | Cohort A |
Primary outcome
Progression Free Survival
Time frame: 36 months
Time to recurrence or progression
Intra- and postoperative complications, incidence of lymph oedema
Time frame: 36 months
4 secondary outcomes
Overall survival
Time frame: 36 months
Rate of locoregional relapse and rate of distant metastases at 3 years.
Time frame: 36 months
Pelvic organ functioning
Time frame: 36 months
QoL
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingEarly Phase 1
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
PDL1 Gene Mutation, Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rainer Kimmig, Prof. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Dr. Paul Buderath at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Buderath, Dr. (+492017232442, paul.buderath@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020; AzTrials last refreshed its copy on 3 Nov 2026.