Clinical trial NCT01304667: Chemo- and Radiotherapy in Epithelial Vulvar Cancer
Official title: Chemo- and Radiotherapy in Epithelial Vulvar Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer
Keywords: Vulvar cancer
Radiotherapy
Chemotherapy
Lead sponsor: AGO Study Group
Sponsor class: OTHER
Collaborators: name: medac GmbH
name: Philipps University Marburg
First posted: 2011-02-25
Enrollment: 1618
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: All patients with primary squamous cell cancer of the vulva \> stage Ia who were diagnosed and received treatment between 1998 and 2008 at the participating centres will be included in the study. Furthermore patients with recurrent disease diagnosed and treated at the participating centres during the same time period can be included given that they not only underwent surgical excision for treatment.

For centers with restricted resources for data entry an alternative study collective was defined:

All Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment at the participating centres between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radio/chemotherapy for other reasons.

The participating centers themselves have to decide which study collective they are documenting, dependent on their available resources.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of several specific characteristics
timeFrame: Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department of Gynecology
name: Sven Mahner, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 therapy in lymph node-positive vulvar cancer: the AGO-CaRE-1 study. J Natl Cancer Inst. 2015 Jan 24;107(3):dju426. doi: 10.1093/jnci/dju426. Print 2015 Mar.