EUCTR2018-004166-33-IT
Active, not recruiting
Phase 1
ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY
DrugsBleoprim
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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
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;
Outcomes
Primary Outcomes
Not specified
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