C53 C52
Conditions
Interventions
Group 1: Cancer field resection. Depending on tumor stage this accomplished as total mesometrial resection (TMMR), extended mesometrial resection (EMMR) or laterally extended endopelvic resection (LEE
Sponsors
Universitätsklinikum Leipzig
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with histologically proven cervical carcinoma FIGO stages I B to II B or Müllerian vaginal carcinoma FIGO stage I or II without clinical evidence of involvement of the urethrovesical wall. OR: Patients with histologically proven cervical carcinoma FIGO stages IIB / vaginal carcinoma FIGO stage II suspect for urethrovesical wall involvement or cervical carcinoma FIGO stages IIIA, B, IVA / Müllerian vaginal carcinoma FIGO stages III, IVA. In theses cases, the patients must insist on surgical treatment even after consultation with an radio-oncologist for information about the standard therapy.
Exclusion criteria
Exclusion criteria: Compromised general condition (Karnowsky index < 80%) or other comorbidity rendering the necessary surgery an inacceptable risk. Physical or psychological inability to cope with the expected sequelae of the operation. Previous pelvic radiation. Previous major pelvic surgery (excluding simple hysterectomy). Advanced tumors infiltrating derivatives of external somatic coelom. Neuroendocrine tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complications and sequelae of treatment, recurrence-free survival, disease-specific survival. Regular follow-up examinations are performed every 3 months for two years and every 6 months thereafter for 3 years. Documentation of morbidity and sequelae is accomplished using the Franco-Italian glossary (Chassagne et al. Radiother Oncol 1993; 26: 195-202) during the hospital stay of primary treatment and at the aftercare visits. In case of symptoms and/or clinical suspicion of tumor recurrence, pelvic MRI and core biopsies are performed to exclude pelvic recurrences. (PET)CT ± biopsies are done for diagnosis of distant recurrences. In case a patient misses an follow-up appointment, she is contacted via telephone in order to assess her status. If this is not possible, her gynecologist or family physician are contacted. If survival- and recurrence status cannot be retrieved, the central and local cancer registries are contacted for further information. If still no survival-information can be obtained, the patient is declared "lost for follow-up". | — |
Secondary
| Measure | Time frame |
|---|---|
| Histopathological tumor assessment with respect to ontogenetic anatomy, analysis of relapse patterns with regard to ontogenetic anatomy, overall survival. The histopathological assessment is accomplished on the surgical routine specimen. In addition to routine pathological investigations, the different ontogenetic-anatomic structures are identified in the specimen and each structure is assessed for tumor involvement. Recurrence patterns are analyzed using MRI and biopsy data. Overall survival is assessed as described above (primary endpoints). The endpoints are evaluated continuously at the follow-up visits and yearly for all patients who did not present to these appointments. | — |
Countries
Germany
Contacts
Public ContactBenjamin Wolf
Klinik und Poliklinik für GynäkologieUniversitätsklinikum Leipzig
Outcome results
None listed