Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial

Phase 1

• Conditions: relapsing vulvar carcinoma already subjected to multiple treatments; MedDRA version: 21.1Level: LLTClassification code 10026642Term: Malignant neoplasm of vulva recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002614-13-IT
• Lead Sponsor: AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-10
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1.Age = 18 years old
2.Recurrent vulvar carcinoma confirmed by histological examination (sec. WHO 2020)
3.Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), alternatively patient not eligible for standard therapies due to the performance
4.Status life expectancy more than three months
5.Measurable disease according to RECIST 1.1
6.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?)
- 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
7.For females of childbearing potential, a pregnancy test on negative serum within 15 days of Day 1 of the study.
8.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
2.History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
3.Allergic reactions to the two chemotherapy drugs (BLM and CBP) and/or their excipients.
4.Evidence of pulmonary fibrosis.
5.History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification =II [NYHA 1994]), myocardial infarction within 6 months of study entry.
6.Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded).
7.Pregnant or breastfeeding.
8.Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified