Clinical trial NCT05395962: Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Official title: Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Vulvar Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Compare Local progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires in patients undergoing BLM + CBP vs BLM alone assessed with questionnaires.
timeFrame: 5 years
measure: Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the EQ-5D-5L (5-level EQ-5D version) questionnaire.
timeFrame: 5 years
measure: Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACT-V (Functional Assessment of Cancer Therapy-Vulva) questionnaire.
timeFrame: 5 years
measure: Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACIT-PAL ( Functional Assessment of Chronic Illness Therapy - Palliative Care) questionnaire.
timeFrame: 5 years
measure: Compare Overall Survival
timeFrame: 5 years
measure: Reporting of Adverse Events and Serious Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS- Azienda Ospedaliera-Universitaria di Bologna
state: Bo
Study officials:
References: