locally advanced rectal cancer
Conditions
Interventions
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
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: a) Age less than 18 years b) Patients with neoplasia more than 12 cm from the anal margin c) Patients with stable disease or disease progression after neoadjuvant treatment d) Patients, who for medical reasons, cannot be given bleomycin e) Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.); f) Acute lung infection; g) Symptoms of poor lung function; h) Non correctable severe coagulation disorders; i) Previous allergic reactions to bleomycin; j) Previous cumulative dose of 250 mg/m2 of bleomycin exceeded; k) Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin) l) Pregnancy or lactation** **Pregnancy has been established prior to enrolment by beta-HCG assay on urine (pregnancy test or urinary beta-HCG) or blood (plasma beta-HCG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: a) Local recurrence rate b) Pain control c) Quality of life d) Electrochemotherapy toxicity ;Primary end point(s): Incremento del tasso di risposta completa istopatologica del braccio di trattamento rispetto al braccio di controllo;Timepoint(s) of evaluation of this end point: At visit 4 (37 ± 5 days from treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactPaolo Delrio
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Outcome results
None listed