Electrochemotherapy for vulvar cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS- Azienda Ospedaliera-Universitaria di Bologna
  Bologna, Bo, Italy Recruiting

Study contacts

• Study coordinator: Anna Myriam Perrone, MD
• Email: myriam.perrone@aosp.bo.it
• Phone: +393498359048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.