Advanced Inoperable Vulva CarcinomaNCT03142061
Electrochemotherapy for the Inoperable Vulva Carcinoma
A study testing Electrochemotherapy in people with Advanced Inoperable Vulva Carcinoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Advanced Inoperable Vulva Carcinoma
- What is being tested?
- Electrochemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Interventional
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- age ≥ 55 years (postmenopausal)
- histologically proved cutan accessible vulva carcinoma
- a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
- applied electrochemotherapy with electroporation
Who cannot join
- Non compliant patients
- Patients with symptomatic or rapidly progredient metastasis outside of the vulva
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma
Read the detailed description
Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .
- Conditions
- Advanced Inoperable Vulva Carcinoma
- Being tested
- Electrochemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrochemotherapyProcedure or surgery
Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma
| Study group | Role | What they receive |
|---|---|---|
| ECT | Experimental | Not described Receives: Procedure: Electrochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local tumor control
according to RECIST criteria
Measured: Baseline
Symptom control
exulceration, secretion
Measured: Baseline
Secondary outcomes (2)
Life quality
EORTC QLQ
Measured: Baseline, 3, 6 months
Pain
Visual scale
Measured: Baseline, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Inoperable Vulva CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142061
- Sponsor's protocol ID
- 558/2015BO1
- Status last verified
- Feb 2020
- First submitted
- 3 May 2017
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
- ClinicalTrials.gov ID
- NCT03142061
- Acronym / sponsor ID
- 558/2015BO1
- Conditions
- Advanced Inoperable Vulva Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma
Detailed description
Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT | Experimental | Procedure: Electrochemotherapy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent
- age ≥ 55 years (postmenopausal)
- histologically proved cutan accessible vulva carcinoma
- a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
- applied electrochemotherapy with electroporation
Key exclusion criteria (2 listed)
- Non compliant patients
- Patients with symptomatic or rapidly progredient metastasis outside of the vulva
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrochemotherapyBleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma | Procedure or surgery | ECT |
Primary outcome
local tumor control
Time frame: Baseline
according to RECIST criteria
Symptom control
Time frame: Baseline
exulceration, secretion
2 secondary outcomes
Life quality
Time frame: Baseline, 3, 6 months
Pain
Time frame: Baseline, 3, 6 months
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 22 Jul 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrochemotherapy in people with Advanced Inoperable Vulva Carcinoma, run by University Hospital Tuebingen 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 5 inclusion and 2 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 22 Jul 2024. 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?
local tumor control (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2024.