Radio/Chemotherapy in Node Positive Advanced Vulvar CancerCARENCT01304667
Chemo- and Radiotherapy in Epithelial Vulvar Cancer
An observational study of Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer, run by AGO Study Group at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer
- How many people
- 1,618 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Vulvar cancer, Radiotherapy, Chemotherapy
- Medical subject headings
- Vulvar Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radio/Chemotherapy in Node Positive Advanced Vulvar CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- medac GmbH, Philipps University Marburg
- Responsible party
- Sponsor
- Investigators
- Sven Mahner, MD PhD, Principal investigator, University Medical Center Hamburg-Eppendorf, Department of Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304667
- Sponsor's protocol ID
- AGO-VOP.1 / CARE
- Acronym
- CARE
- Status last verified
- Dec 2015
- First submitted
- 24 Feb 2011
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25618900
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemo- and Radiotherapy in Epithelial Vulvar Cancer
- ClinicalTrials.gov ID
- NCT01304667
- Acronym / sponsor ID
- CARE / AGO-VOP.1 / CARE
- Keywords
- Vulvar cancer, Radiotherapy, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,618 participants (actual)
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Collaborators
- medac GmbH, Philipps University Marburg
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of several specific characteristics
Time frame: Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi
* 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Results publication: PubMed 25618900Mahner 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Mahner, MD PhD principal investigator
University Medical Center Hamburg-Eppendorf, Department of Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer, run by AGO Study Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of several specific characteristics (time frame: Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.