NCT01304667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,618

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 10, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

February 24, 2011

Last Update Submit

May 9, 2016

Conditions

Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer

Keywords

Vulvar cancerRadiotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with primary squamous cell vulvar cancer except stage Ia disease regardless of the received treatment
  • Patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision.
  • 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.
  • Patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008
  • Women aged ≥ 18 years

You may not qualify if:

  • Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of the vulva
  • Patients with non-squamous neoplasia of the vulva (e.g. melanoma)
  • Patients with verrucous vulvar cancer
  • Patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment.
  • Patients with secondary cancers if those interfered with the treatment of vulvar disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25618900RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subproject of Translational Research: Paraffin embedded tissue samples were collected.

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sven Mahner, MD PhD

    University Medical Center Hamburg-Eppendorf, Department of Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 10, 2016

Record last verified: 2015-12

Locations

DE(1)