ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY

INTERVENTION: Trade Name: Bleoprim Product Name: Bleoprim Pharmaceutical Form: Powder for injection INN or Proposed INN: BLEOMYCIN CAS Number: 11056‐06‐7 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1500‐ CONDITION: locally advanced rectal cancer Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Increase of the complete response rate with the aim of organ sparing. Evaluated by histopathological analysis based on TRG performed on specimen exported from local excision. Primary end point(s): Incremento del tasso di risposta completa istopatologica del braccio di trattamento rispetto al braccio di controllo Secondary Objective: a) Local recurrence rate ; b) Pain control; c) Quality of life; d) Electrochemotherapy toxicity; Timepoint(s) of evaluation of this end point: At visit 4 (37 ± 5 days from treatment) SECONDARY OUTCOME: Secondary end point(s): a) Local recurrence rate ; b) Pain control; c) Quality of life; d) Electrochemotherapy toxicity; Timepoint(s) of evaluation of this end point: For end points a) the detection will be performed at 60 months from the treatment while for the end points b), c) and d) at each follow‐up visit for the 24 months following the treatment INCLUSION CRITERIA: a) Male or female patients aged > 18 years b) Histological confirmation of rectal adenocarcinoma c) Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment d) Rectal tumor up to 12 cm from the external anal margin e) Patients must be willing to comply with the study protocol and give their informed written consent. f) Patients with an ECOG status performance <3 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 30