OncoMatch/Clinical Trials/NCT05395962
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Is NCT05395962 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Carboplatin and Bleomycin for vulvar cancer.
Treatment: Carboplatin · Bleomycin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Prior therapy
Must have received: surgery
Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
Must have received: radiation therapy
Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
Must have received: chemoradiation
Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
Must have received: chemotherapy
Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 10^9/L, INR >1.5
Kidney function
Serum creatinine <1.5 mg/dl and creatinine clearance > 30 ml/min
Liver function
AST/SGOT, ALT/SGPT ≤3.0 × ULN; Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert's syndrome
Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows: Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 10^9/L) o INR >1.5; AST/SGOT, ALT/SGPT ≤3.0 × ULN; Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert's syndrome; Serum creatinine <1.5 mg/dl and creatinine clearance > 30 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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