Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer Clinical Trial
— CAREOfficial title:
Chemo- and Radiotherapy in Epithelial Vulvar Cancer
| Verified date | December 2015 |
| Source | AGO Study Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy. Application of chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore extended to relapsed disease.
| Status | Completed |
| Enrollment | 1618 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients with primary squamous cell vulvar cancer except stage Ia disease regardless of the received treatment 2. Patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision. 3. Or alternatively, dependent on the decision of the participating center: -Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment regardless of nodal involvement. 4. Patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008 5. Women aged = 18 years Exclusion Criteria: 1. Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of the vulva 2. Patients with non-squamous neoplasia of the vulva (e.g. melanoma) 3. Patients with verrucous vulvar cancer 4. Patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment. 5. Patients with secondary cancers if those interfered with the treatment of vulvar disease |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| AGO Study Group | medac GmbH, Philipps University Marburg Medical Center |
Germany,
Mahner S, Jueckstock J, Hilpert F, Neuser P, Harter P, de Gregorio N, Hasenburg A, Sehouli J, Habermann A, Hillemanns P, Fuerst S, Strauss HG, Baumann K, Thiel F, Mustea A, Meier W, du Bois A, Griebel LF, Woelber L; AGO-CaRE 1 investigators. Adjuvant ther — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determination of several specific characteristics | Determination of the fraction of node positive patients to estimate the number of participating centers and sample size for a subsequent prospective trial. Determination of the prognostic impact of the number of positive lymph nodes and the stage of disease to define indication criteria for adjuvant radio/chemotherapy for a subsequent prospective trial. Identification of indication criteria for adjuvant/therapeutic/palliative radio/chemotherapy |
Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi | No |