Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

TMMR Register Study (TMMR-RS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Essen
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Buderath, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01819077
First received: March 19, 2013
Last updated: March 23, 2013
Last verified: March 2013
  Purpose

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 Intervention
Cervical Cancer
Procedure: TMMR

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 500
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)
Groups/Cohorts Assigned Interventions
TMMR
Patients with cervical cancer Stages IB - IIA treated with TMMR and tLNE
Procedure: TMMR

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819077

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

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

Publications:
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
Study First Received: March 19, 2013
Last Updated: March 23, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Essen:
Cervical cancer
TMMR
therapeutic lymphadenectomy
register study

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

ClinicalTrials.gov processed this record on November 25, 2014