melanoma MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: INDERAL - 80 MG CAPSULE RIGIDE A RILASCIO PROLUNGATO 28 CAPSULE
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: PROPRANOLOLO
Current Sponsor code: SIS:2638
Other descrip
Sponsors
AZIENDA SANITARIA DI FIRENZE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-75 years old with newly diagnosed histologically proven resected melanoma; 2. Stage: Ib (T1b, T2a), IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0; IIIA (N1a, N1b) 3. Signed Informed Consent; 4. Performance Status of 0-1 (ECOG); 5. Hematopoietic functionality at the entry of the study: leukocytes, platelets, hemoglobin and neutrophils within the normal limits of laboratory references; 6. Hepatic and renal functionality at the entry of the study: LDH, bilirubin, AST, ALT, alkalinephosphatase, BUN and serum creatinine within the normal range of each laboratory; 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 3
Exclusion criteria
Exclusion criteria: 1. Primary not cutaneous melanoma; 2. Clinical/radiological evidence or laboratory/pathology report of not completely resectedmelanoma; 3. History of cancer 4. Current use or past use in the last two years of any b-blockers for any other medical condition 5. Current use of verapamil, diltiazem or similar calcium channel blocker 6. Current use of centrally acting antihypertensive drugs as a-methyldopa, clonidine 7. Hypersensitivity to propranolol or to any of the excipients; 8. Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy; 9. Cardiogenic shock; 10. Sinoatrial block ; 11. Second or third degree atrio-ventricular block; 12. Marked bradycardia (less than 60 beats/min) ; 13. Extreme hypotension (systolic blood pressure <100mmHg) ; 14. Severe asthma or severe chronic obstructive pulmonary disease ; 15. Sick sinus syndrome; 16. Severe forms of peripheral arterial occlusive disease and Raynaud's syndrome; 17. Metabolic acidosis 18. Asthma 19. Diabetes 20. Heart failure 21. History of psoriasis 22. Pregnancy or breast feeding or planning on becoming pregnant during the 3 years of treatment; 23. Any medical condition that in the physician’s opinion would potentially interfere with the patient ability to adhere to protocol and treatment; 24. Any logistic condition that do not allow follow-up of the disease of the patient. 25. Hypersensitivity to propranolol, child bearing or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the effect of treatment with propanololo 80 mg retard on overall survival for melanoma patients in stage II/IIIA (T2, N0 or N1, M0) at 5 years follow-up after at least one years of treatment;Secondary Objective: to evaluate the effect of treatment on disease free survival at five years follow-up in patinets stage II/IIA to evaluate the effect of treatment of specific mortality for melanoma to evaluate the long term safaty of treatment in patient with melanoma stage II/IIIA to evaluate the adherence to propanololo treatment (compliance);Primary end point(s): ndn | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) will be the primary end-point of efficacy in this Phase III trial. It is defined as the time from the date of randomization to the date of death from any cause or to the date of last follow-up. Every effort should be made to document the latest date of follow-up/date of death and the cause of death. Patients still alive at the latest follow-up will be considered as censored observations.; We will include in this study histologically confirmed CMM diagnosed before their recruitment (date at interview) in the trial and before the end of the last follow-up period. We will evaluate progression or death before the end of the last follow-up period. | — |
Countries
Italy
Contacts
Public Contactstruttura coordinamento ricerca cli
azienda sanitaria firenze
Outcome results
None listed