Trial · NCT05395962
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
NCT05395962, Phase 2, Recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer. Trials, record NCT05395962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05395962
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
- NCT number
- NCT05395962
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 92 participants, estimated
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Conditions
- Vulvar Cancer
- Interventions
- Carboplatin, Bleomycin
- First posted
- 2022-05-27
- Last updated
- 2022-05-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare Local progression-free survival | 5 years | Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments. |
| Secondary | Compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires in patients undergoing BLM + CBP vs BLM alone assessed with questionnaires. | 5 years | Paper or electronic questionnaires will be given to the patient at baseline (within 30 days prior to randomization) and then at every follow-up visit within the first year after randomization.The significance and relevance of the data need to be explained carefully to participating patients so that they are motivated to comply with data collection. The patient must complete the questionnaire him/herself without receiving help from relatives, friends or clinic staff to answer the questionnaire. However, if the patient is unable to read the questionnaire (e.g., is blind or illiterate) the questionnaire may be read out by trained clinic staff and responses recorded. |
| Secondary | Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the EQ-5D-5L (5-level EQ-5D version) questionnaire. | 5 years | The EQ-5D-5L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. |
| Secondary | Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACT-V (Functional Assessment of Cancer Therapy-Vulva) questionnaire. | 5 years | The FACT-V is a supplemental module that contains questions specifically related to the quality of life of patients with VC. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The response scale is a 5-point Likert type scale. The FACT-V is also has additional questions regarding issues that may be affected by vulvar cancer. |
| Secondary | Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACIT-PAL ( Functional Assessment of Chronic Illness Therapy - Palliative Care) questionnaire. | 5 years | The FACIT-PAL ( is a 19-item palliative care subscale with items that pertain to persons with life-limiting illness. This questionnaire has items that pertain to symptoms that can be seen in advanced illness (e.g., shortness of breath, constipation, xerostomia), family and friend relationships (e.g., feeling appreciated by family, being a burden to family, maintaining contact with friends), life closure issues (e.g., having "made peace" with others, feeling hopeful, making "each day count"), and decision-making and communication abilities. The response scale is a 5-point Likert type scale. |
| Secondary | Compare Overall Survival | 5 years | To compare Overall Survival in the two study arms. |
| Secondary | Reporting of Adverse Events and Serious Adverse Events | 5 years | Toxicity will be evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events) criteria based on AE (Adverse Events) related or possibly related to the procedure and the drugs utilized, and to SAE (Serious Adverse Event) and AESI (Adverse Events of Special Interest), whether or not the event is considered treatment related. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05395962
GET https://conductscience.org/api/trials/v1/NCT05395962/registered