Register Study: TMMR and Therapeutic Lymphadenectomy According to M.Hoeckel for Treatment of Cervical Cancer FIGO IB-IIA

Rationale for the multimodal treatment of cervical cancer in FIGO stages IB-IIA according to M. Hoeckel: Total mesometrial resection (TMMR) is a newly developed procedure for surgical treatment of cervical cancer of FIGO stage IB to IIB. The procedure is based on embryologically determined surgical anatomy that was generated from investigations of the embryonal and fetal development of the Müllerian organ system and of local tumor spread of cervical cancer at the macroscopic, microscopic and molecular level (11-13). The observation that the cervical cancer follows the embryologically derived compartment hierarchy led to the definition of a new principle of radicality for oncological surgery, i.e., the resection of a tumor within the borders of the compartment representing the morphogenetic unit of the tumor origin. A resection that follows this principle leads to high local control (>95%) without additional radiotherapy. The resection line of the vagina is located inside the compartment, therefore intraoperative frozen section examination of the TMMR specimen is necessary to achieve wide margins. Adjacent structures that belong to another morphogenetic unit can be saved in spite of immediate proximity to the tumor. The autonomic nerves are saved with the TMMR concept as well as the ureters, the urinary bladder and their mesenteries containing all blood vessels, and the rectum with the mesorectum.

Therapeutic LNE: With TMMR tLNE has to be done with therapeutic intent, so that in case of lymph node metastases a high regional tumor control without adjuvant radiotherapy can be achieved (27). Therapeutic pelvic tLNE needs the removal of the lymph node groups within the scope of the classical systematic pelvic LNE and additionally, the paravisceral fatty tissue inferior to the obturator nerve, perispinal, gluteal and presacral lymph nodes to S2. The therapeutic pelvic LNE is done with exposition and protection of the plexus hypogastricus superior, the nervus hypogastricus and the plexus hypogastricus inferior and all ureter supplying vessels, bilaterally. In case of intraoperative evidence of pelvic lymph node metastases in first line nodes stepwise ascending therapeutic para-aortic LND with protection of the plexus hypogastricus superior and the nervi splanchnici lumbales has to be done. To date no prospective, randomized trial has proven a survival benefit of adjuvant chemotherapy alone in patients with early cervical cancer and histopathological risk factors. However, retrospective studies and the results of Peters et al. (20), comparing adjuvant chemo-radiotherapy with radiotherapy alone in patients after surgery for cervical cancer suggest that adjuvant chemotherapy may exert an impact on survival. The possible effect of adjuvant chemotherapy should be taken into consideration when applying only surgical therapeutic concepts (23;25). Therefore, adjuvant chemotherapy in case of risk factors was performed Hoeckel's trial. The mono-institutional prospective study of the University of Leipzig, Department of Gynecology and Obstetrics, has shown that the treatment concept for cervical cancer FIGO stages IB-IIB including TMMR and therapeutic LNE without adjuvant radiotherapy achieves a markedly improved therapeutic index in comparison with historic controls (16;22): locoregional control was 96% versus 91%, relapse-free survival after three years was 93% vs. 84%, treatment-caused side effects were 9% exclusively grade II vs. 28% grade II and III (11-13).

Scientific aims

1. Observation of results of standardization of radical hysterectomy and therapeutic lymphadenectomy in cervical cancer FIGO IB -IIA on the basis of ontogenetically defined compartment theory in a multicentric approach by TMMR/LND in clinical routine
2. Assessment of locoregional recurrence in this concept without any radiation therapy showing that postoperative irradiation and associated morbidity can also be avoided and irradiation may be maintained for rescue in recurrency under conditions of clinical routine
3. Confirmation of the low morbidity of TMMR due to autonomous nerve and vessel preservation by concomitant urogynecological and psychosexual subprotocols in clinical routine treatment

Requirements for participating centers of the register study