NCT03142061

Brief Summary

Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 22, 2024

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

May 3, 2017

Last Update Submit

July 19, 2024

Conditions

Advanced Inoperable Vulva Carcinoma

Outcome Measures

Primary Outcomes (2)

  • local tumor control

    according to RECIST criteria

    Baseline

  • Symptom control

    exulceration, secretion

    Baseline

Secondary Outcomes (2)

  • Life quality

    Baseline, 3, 6 months

  • Pain

    Baseline, 3, 6 months

Study Arms (1)

ECT

EXPERIMENTAL
Procedure: Electrochemotherapy

Interventions

ElectrochemotherapyPROCEDURE

Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma

ECT

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Women's Health

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Electrochemotherapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsElectroporation TherapiesElectroporationCytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

December 31, 2019

Last Updated

July 22, 2024

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)