TMMR (Total Mesometrial Resection) Register Study (TMMR-RS)
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||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|
- Progression-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]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.
- Overall Survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]Overall survival, defined as time from TMMR to death of any cause; Rate of locoregional relapse and rate of distant metastases at 3 years.
- Sexual and bladder function [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Postoperative dysfunction of the bladder/urethra and of psychosexual function, assessed as described in the urogynecological and psychosexual subprotocol
- Quality of Life [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]Postoperative Quality of Life as measured by the EORTC-QLQ-C30 questionnaire
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Patients with cervical cancer Stages IB - IIA treated with TMMR and tLNE
Radical hysterectomy by Total Mesometrial Resection (TMMR) and therapeutic lymphadenectomy (tLNE)
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819077
|Contact: Rainer Kimmig, Prof. Dr.||firstname.lastname@example.org|
|Contact: Paul Buderath, Dr.||email@example.com|
|University Hospital Essen||Recruiting|
|Essen, NRW, Germany, 45122|
|Contact: Rainer Kimmig, Prof. Dr. 00492017232241 firstname.lastname@example.org|
|Contact: Paul Buderath, Dr. 004920172385293 email@example.com|
|Principal Investigator: Rainer Kimmig, Prof. Dr.|
|Principal Investigator: Paul Buderath, Dr.|
|Principal Investigator:||Rainer Kimmig, Prof. Dr.||University Hospital, Essen|