Electrochemotherapy for the Inoperable Vulva Carcinoma | NCT03142061

Studies
Electrochemotherapy for the Inoperable Vulva Carcinoma

NCT03142061

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jul 22, 2024Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Advanced Inoperable Vulva Carcinoma

Interventions

Electrochemotherapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jun 1, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

May 3, 2017

First Submission Date that Met QC Criteria

May 3, 2017

First Posted Date

May 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2024

Last Update Posted Date

Jul 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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. .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECT	Experimental		Procedure: Electrochemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electrochemotherapy	Procedure	Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma	ECT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
local tumor control	according to RECIST criteria	Baseline
Symptom control	exulceration, secretion	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Life quality	EORTC QLQ	Baseline, 3, 6 months
Pain	Visual scale	Baseline, 3, 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non compliant patients
Patients with symptomatic or rapidly progredient metastasis outside of the vulva

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Women's Health		Tübingen		72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053672	Electrochemotherapy

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics
D000092722	Electroporation Therapies
D018274	Electroporation

Browse Leaves

Not provided

Browse Branches

Not provided