Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer

NCT ID: NCT05395962

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2027-04-07

Brief Summary

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.

Conditions

Vulvar Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BLM

Group Type: ACTIVE_COMPARATOR

Bleomycin

Intervention Type: DRUG

treatment with bleomycin in association with electroporation

BLM+CBP

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

treatment with bleomycin and carboplatin in association with electroporation

Bleomycin

Intervention Type: DRUG

treatment with bleomycin in association with electroporation

Interventions

Carboplatin

treatment with bleomycin and carboplatin in association with electroporation

Intervention Type: DRUG

Bleomycin

treatment with bleomycin in association with electroporation

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Anna Myriam Perrone

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bo, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Anna Myriam Perrone, MD

Role: CONTACT

myriam.perrone@aosp.bo.it

+393498359048

Facility Contacts

Anna Myriam Perrone, MD

Role: primary

myriam.perrone@unibo.it

+39 051 2144392

Other Identifiers

41/2022/Farm/AOUBo

Identifier Type: -

Identifier Source: org_study_id