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TMMR (Total Mesometrial Resection) Register Study (TMMR-RS)

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ClinicalTrials.gov Identifier: NCT01819077
Recruitment Status : Recruiting
First Posted : March 27, 2013
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in high risk situations. More and more this therapeutic strategy is implemented in clinical routine in specialized cancer centres, thus, treatment of cervical cancer could be performed for these stages in a systematically defined and reproducible radicality; adjuvant radiotherapy could be spared for recurrent disease, thus lowering morbidity and resource assignment in primary treatment dramatically. Due to the nerve-sparing character of the procedure bladder, bowel and sexual dysfunction would also be minimized and markedly benefit the patient.

This study is designed to follow up the results of this therapeutic concept adapted to clinical routine in a multiinstitutional register study accompanied by detailed assessment of pathological work-up, quality of life and bladder and sexual function following surgery.

Condition or disease Intervention/treatment
Cervical Cancer Procedure: TMMR

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Register Study: TMMR and Therapeutic Lymphadenectomy According to M.Hoeckel for Treatment of Cervical Cancer FIGO IB-IIA
Study Start Date : March 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients with cervical cancer Stages IB - IIA treated with TMMR and tLNE
Procedure: TMMR
Radical hysterectomy by Total Mesometrial Resection (TMMR) and therapeutic lymphadenectomy (tLNE)

Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 60 months ]
    Progression-free survival, defined as time from TMMR to a local or regional relapse, of a distant metastasis or to death of any cause whichever event comes first. Simultaneous occurrence of pelvic and distant metastases is considered as distant but should be documented in detail.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 60 months ]
    Overall survival, defined as time from TMMR to death of any cause; Rate of locoregional relapse and rate of distant metastases at 3 years.

Other Outcome Measures:
  1. Sexual and bladder function [ Time Frame: 24 months ]
    Postoperative dysfunction of the bladder/urethra and of psychosexual function, assessed as described in the urogynecological and psychosexual subprotocol

  2. Quality of Life [ Time Frame: 60 months ]
    Postoperative Quality of Life as measured by the EORTC-QLQ-C30 questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cervical cancer Stages IB - IIA treated with TMMR and tLNE.

Inclusion Criteria:

  • Histologically proven cervical cancer: squamous cell carcinoma or adenocarcinoma; FIGO stages IB - IIA (preoperatively); Karnofsky-Index ≥ 70; unrestricted operability; BMI <35; age >=18 years.
  • Individual decision for treatment of TMMR and therapeutic LNE without adjuvant radiotherapy by the responsible clinic (clinician) on a clinical routine basis.
  • Informed consent of the patient

Exclusion criteria:

  • Neuroendocrine differentiation and all preoperative FIGO stage IA or >IIA;
  • Distant metastases except in para-aortic lymph nodes; sclerodermia, lupus erythematodes, mixed connective tissue disease; secondary malignancy; previous radiotherapy of the pelvis.
  • Patients with diseases of the connective tissue will be excluded because of unforeseeable (e.g. neurological) symptoms and disorders after surgery. Patients with a BMI ≥ 35 will be excluded because of very high risks regarding wound healing, infections and thrombosis independent on the type of surgery.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819077

Contact: Rainer Kimmig, Prof. Dr. 00492017232241 rainer.kimmig@uk-essen.de
Contact: Paul Buderath, Dr. 004920172385293 paul.buderath@uk-essen.de

University Hospital Essen Recruiting
Essen, NRW, Germany, 45122
Contact: Rainer Kimmig, Prof. Dr.    00492017232241    rainer.kimmig@uk-essen.de   
Contact: Paul Buderath, Dr.    004920172385293    paul.buderath@uk-essen.de   
Principal Investigator: Rainer Kimmig, Prof. Dr.         
Principal Investigator: Paul Buderath, Dr.         
Sponsors and Collaborators
University Hospital, Essen
Principal Investigator: Rainer Kimmig, Prof. Dr. University Hospital, Essen
More Information

Responsible Party: Dr. Paul Buderath, Prof. Dr. med. Rainer Kimmig, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01819077     History of Changes
Other Study ID Numbers: TMMR-RS
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Dr. Paul Buderath, University Hospital, Essen:
Cervical cancer
therapeutic lymphadenectomy
register study

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female