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NCT05395962: Elechtra
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Phase 2 trial testing Carboplatin in Vulvar Cancer in 92 participants. Currently enrolling.
7 April 2025
Quick facts
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 8 April 2022 |
| Primary completion | 7 April 2025 |
| Estimated completion | 7 April 2027 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Carboplatin (Carboplatin) — full drug profile →
- Bleomycin (BLEOMYCIN) — full drug profile →
Conditions studied
- Vulvar Cancer — all drugs for Vulvar Cancer →
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →
Who can join
18 and older, female only, with Vulvar Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with vulvar cancer who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), or patients not eligible for standard therapies. The study aims to: * Evaluate the oncology response to electroporation after administration of Bleomycin (BLM) + carboplatinum (CBP )to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments. * Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5). * To compare Overall Survival in the two study arms. * To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms. * To compare costs and cost-effectiveness between the two study arms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05395962
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Currently open trials in the same condition.
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Other IRCCS Azienda Ospedaliero-Universitaria di Bologna trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05395962 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Last refreshed: 27 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05395962.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing