primary cutaneous melanoma MedDRA version: 20.0 Level: LLT Classification code 10027155 Term: Melanoma skin System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bleomicina Accord
Product Name: Bleomicina Accord
Product Code: [Bleomicina Accord]
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bleomicina
CAS Number: 11056
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Histologically confirmed diagnosis of cutaneous melanoma Stage of disease: single, primary, localized cutaneous melanoma 2 mm or greater in thickness Breslow on the trunk or limbs (excluding soles of the feet) Performance status (PS) according to The Eastern Cooperative Oncology Group (ECOG) = 2 Written informed consent Use of an acceptable mean of contraception for men and women of childbearing potential 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Diagnosis of mestastatic melanoma. • Serious coagulation abnormality, INR above 1.5 • Absolute neutrophil count below 1,000/ml • Platelet count below 70,000/ml • Hemoglobin = 9 gr/dl • Known allergies to Bleomycin • Cumulative lifetime dose of Bleomycin exceeding 250 mg/m2 • Peripheral neuropathy greater than grade 2 • Chronic renal deficiency (creatinine>1.5 µg/L) • Active infection • Cardiac arrhythmias [e.g., significant ventricular arrhythmia such as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrioventricular block 2 and 3, sinoatrial block] • Epilepsy • Pregnant or breastfeeding • Any other cancer from which the patients had been disease free for less than 5 years (except treated and cured basal–cell or squamous-cell skin cancer, superficial bladder cancer, or treated carcinoma in situ of the cervix, breast, or bladder) • Pulmonary infection • Severely impaired lung function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the rate of complications, defined as grade =3 adverse events [according to the Common Terminology Criteria for Adverse Events of the National Cancer Institute (NCI-CTCAE) version 5.0], of surgical excision margins compared to Electrochemotherapy in patients with cutaneous melanoma after the primary tumor excission.;Secondary Objective: To compare the two arm in terms of: • Quality of life [(European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30; EuroQol five-dimensional(EQ-5D-5L) and Derriford Appearance Scale (DAS 24) questionnaires] • Costs • Pain Assessment [Visual Analogue Scale (VAS)] • Local recurrence rate (defined as the combination of local recurrence, in transit recurrence and regional node metastasis) • Disease-free survival;Primary end point(s): • To evaluate the rate of complications, defined as grade =3 adverse events [according to the Common Terminology Criteria for Adverse Events of the National Cancer Institute (NCI-CTCAE) version 5.0], of surgical excision margins compared to Electrochemotherapy in patients with cutaneous melanoma after the primary tumor excission.;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Quality of life [(European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30; EuroQol five-dimensional(EQ-5D-5L) and Derriford Appearance Scale (DAS 24) questionnaires] 2 Costs 3 Pain Assessment [Visual Analogue Scale (VAS)] 4 Local recurrence rate (defined as the combination of local recurrence, in transit recurrence and regional node metastasis) 5 Disease-free survival;Timepoint(s) of evaluation of this end point: 1 -Questionnaires must be compiled by the patients before any study procedure but within 30 days prior to randomization (Visit 1, baseline) and at pre -treatment visit (Visit 2, Day -1), at wound evaluation visits (Visit 4, Day 1 and Visit 5, Day 15) and at follow-up visit (Visit 6, non more than 30 calendars days after treatment) in both treatment arms. 3 -Questionnaires must be compiled by the patients before any study procedure but within 30 days prior to randomization (Visit 1, baseline) and at pre -treatment visit (Visit 2, Day -1), treatment visit (visit 3, Day0) at wound evaluation visits (Visit 4, Day 1 and Visit 5, Day 15) and at follow-up visit (Visit 6, non more than 30 calendars days after treatment) in both treatment arms. 4 -after 1 month | — |
Countries
Italy
Contacts
Public ContactUnità Sperimentazioni Cliniche
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Outcome results
None listed