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

Phase 1

• Conditions: locally advanced rectal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004166-33-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-11
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>b) Pain control<br>c) Quality of life<br>d) Electrochemotherapy toxicity<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): a) Local recurrence rate <br>b) Pain control<br>c) Quality of life<br>d) Electrochemotherapy toxicity<br>;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