EMBRACE Vaginal Morbidity Study

Completed

Conditions: cancer of the cervix
10013364
cervical cancer

Registration Number: NL-OMON39692

Lead Sponsor: Medical University of Vienna, Austria Department of Radiotherapy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

- Cancer of the uterine cervix suitable for curative treatment with definitive radio-(chemo)therapy including 3D image guided Brachytherapy.
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- Staging according to FIGO and TNM guidelines
- FIGO stage IB1-IIIB, without vaginal extension (stage IIA and IIIA not allowed)
- Para-aortic metastatic nodes below L1-L2 are allowed
- Patient informed concent
- Ability to read, understand and fill in questionaires on quality of life and sexuality

Exclusion Criteria

- Other primairy malignancies exept carcinoma in situ of the cervix and basal cell carcinoma of the skin.
- Metastatic disease beyond para-aortic region (L1-L2)
- Vaginal extension of primary tumor.
- Pre-existent major vaginal morbidity.
- Previous pelvic or abdominal radiotherapy
- Combination of preoperative radiotherapy with surgery
- Patients receiving BrachyTherapy only.
- Patients receiing ExternalBeamRadioTherapy only.
- Patients receiving neoadjuvant chemotherapy
- Cotraindications to BrachyTherapy
- Active infection or severe medical condition endagering treatment delivery

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Vaginal changes, reported by patient and radiotherapist, and the complex<br /><br>interaction of the physical, dosimetric, biological, clinical and psychological<br /><br>factors to vaginal morbidity and the importance of these factors to sexual<br /><br>functioning and health related quality of life. </p><br>

Secondary Outcome Measures