Clinical trial · Observational
TMMR (Total Mesometrial Resection) Register Study
Register Study: TMMR and Therapeutic Lymphadenectomy According to M.Hoeckel for Treatment of Cervical Cancer FIGO IB-IIA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TMMR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TMMR
- description
- Patients with cervical cancer Stages IB - IIA treated with TMMR and tLNE
- interventionNames
- Procedure: TMMR
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 60 months
- description
- 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 outcomes (1)
- measure
- Overall Survival
- timeFrame
- 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDHockel M, Horn LC, Hentschel B, Hockel S, Naumann G. Total mesometrial resection: high resolution nerve-sparing radical hysterectomy based on developmentally defined surgical anatomy. Int J Gynecol Cancer. 2003 Nov-Dec;13(6):791-803. doi: 10.1111/j.1525-1438.2003.13608.x. PMID 14675316
- BACKGROUNDHockel M. Do we need a new classification for radical hysterectomy? Insights in surgical anatomy and local tumor spread from human embryology. Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S106-12. doi: 10.1016/j.ygyno.2007.07.049. Epub 2007 Aug 28. PMID 17727931
- BACKGROUNDHockel M, Horn LC, Tetsch E, Einenkel J. Pattern analysis of regional spread and therapeutic lymph node dissection in cervical cancer based on ontogenetic anatomy. Gynecol Oncol. 2012 Apr;125(1):168-74. doi: 10.1016/j.ygyno.2011.12.419. Epub 2011 Dec 8. PMID 22155677
- DERIVEDBuderath P, Stukan M, Ruhwedel W, Strutas D, Feisel-Schwickardi G, Wimberger P, Kimmig R. Total mesometrial resection (TMMR) for cervical cancer FIGO IB-IIA: first results from the multicentric TMMR register study. J Gynecol Oncol. 2022 Jan;33(1):e9. doi: 10.3802/jgo.2022.33.e9. Epub 2021 Dec 6. PMID 34910390