Electrochemotherapy for vulvar cancer treatment

Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial

This study is testing if a new treatment called electrochemotherapy, which combines two drugs, can help women with relapsed vulvar cancer feel better and live longer compared to using just one of the drugs.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Bologna, Bo)
• Trial ID: NCT05395962 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of electrochemotherapy using a combination of carboplatin and bleomycin compared to bleomycin alone in women with relapsed vulvar cancer who have undergone multiple prior treatments. The study aims to assess local progression-free survival, overall survival, quality of life, and the safety profile of both treatment arms. Patients will be monitored for local and systemic toxicity, morbidity, mortality, and the cost-effectiveness of the interventions. The trial includes patients who are not eligible for standard therapies due to their performance status.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with recurrent vulvar cancer who have previously undergone multiple treatments and are not eligible for standard therapies.

Not a fit: Patients with early-stage vulvar cancer or those who are eligible for standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with relapsed vulvar cancer who have limited therapeutic choices.

How similar studies have performed: Other studies have shown promising results with electrochemotherapy in various cancers, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old
* Recurrent VC confirmed by histological examination
* Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
* Patient not eligible for standard therapies (surgery, radiation therapy and systemic chemotherapy in case of metastatic disease) due to the performance status (ECOG Performance Status ≥ 3 )
* Life expectancy more than three months
* Measurable disease according to RECIST 1.1
* 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 × 109/L?) o INR \>1.5;
  * Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (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 All blood assessments must be performed within 15 days from ECT treatment.
* For females of childbearing potential, a negative serum pregnancy human chorionic gonadotropin (hCG) pregnancy test within 72 hours of study Day 1.
* Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply the study requirements.

Exclusion Criteria:

* History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
* History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
* Allergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/or their excipients.
* Evidence of pulmonary fibrosis.

Where this trial is running

Bologna, Bo

• IRCCS- Azienda Ospedaliera-Universitaria di Bologna — Bologna, Bo, Italy (RECRUITING)

Study contacts

• Study coordinator: Anna Myriam Perrone, MD

Conditions: Vulvar Cancer