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ovel surgical treatment approaches based on ontogenetic anatomy for vaginal and cervical cancer: TMMR, KMMR, EMMR, LEER and tLNE

Not Applicable
Recruiting
Conditions
C53
C52
Malignant neoplasm of cervix uteri
Malignant neoplasm of vagina
Registration Number
DRKS00015171
Lead Sponsor
niversitätsklinikum Leipzig
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
600
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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