Clinical trial • Phase II • Oncology

BLEOMYCIN for Rectal cancer | Colorectal cancer

Phase II trial of BLEOMYCIN for Rectal cancer | Colorectal cancer. 70 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Rectal cancer | Colorectal cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-11-2024
First CTIS Authorization Date
10-01-2025

Trial design

Phase II trial across 7 sites in Italy.

Target Sample Size
70

Eligibility

Recruits 70 No vulnerable population selected. Participants must be adults (≥18 years) and 'Patients must be willing to comply with the study protocol and give their informed written consent.' No assent procedures or paediatric consent described..

Pregnancy Exclusion
Pregnancy or lactation
Vulnerable Population
No vulnerable population selected. Participants must be adults (≥18 years) and 'Patients must be willing to comply with the study protocol and give their informed written consent.' No assent procedures or paediatric consent described.

Inclusion criteria

  • {"criterion_text":"- Male or female patients aged ≥18 years\n- Histological confirmation of rectal adenocarcinoma\n- Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment\n- Rectal tumor up to 12 cm from the external anal margin\n- Patients must be willing to comply with the study protocol and give their informed written consent.\n- Patients with an ECOG status performance <3"}

Exclusion criteria

  • {"criterion_text":"- Age less than 18 years\n- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;\n- Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)\n- Pregnancy or lactation\n- Patients with neoplasia more than 12 cm from the anal margin\n- Patients with stable disease or disease progression after neoadjuvant treatment\n- Patients, who for medical reasons, cannot be given bleomycin\n- Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);\n- Acute lung infection;\n- Symptoms of poor lung function;\n- Non correctable severe coagulation disorders;\n- Previous allergic reactions to bleomycin;"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Evaluation of the safety and feasibility","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Increase in the rate of complete histopathological response in the treatment arm compared to the control arm.","definition_or_measurement_approach":"Evaluated by histopathological analysis based on TRG performed on specimen exported from local excision."}

Recruitment

Planned Sample Size
70
Recruitment Window Months
96
Consent Approach
Informed written consent must be provided by participants themselves (adults ≥18). Consent form documents are listed ('Consenso informato versione 1_1 del 14 Apr 2020'). No paediatric assent procedures or languages specified.

Geography

Total Number Of Sites
7
Total Number Of Participants
70

Italy

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
10-01-2025
Processing Time Days
50
Number Of Sites
7
Number Of Participants
70

Sites

Site Name
Fondazione PTV Policlinico Tor Vergata
Department Name
Department of Surgical Sciences
Principal Investigator Name
Piero Rossi
Principal Investigator Email
piero.rossi@uniroma2.it
Contact Person Name
Piero Rossi
Contact Person Email
piero.rossi@uniroma2.it
Site Name
IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
Department Name
UOC General Surgery
Principal Investigator Name
Gilberto Poggioli
Principal Investigator Email
gilberto.poggioli@unibo.it
Contact Person Name
Gilberto Poggioli
Contact Person Email
gilberto.poggioli@unibo.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
General Surgery, Oncology and Pathological Anatomy
Principal Investigator Name
Giuseppe Navarra
Principal Investigator Email
giuseppe.navarra@unime.it
Contact Person Name
Giuseppe Navarra
Contact Person Email
giuseppe.navarra@unime.it
Site Name
Azienda Sanitaria Locale Della Provincia Di Barletta Andria Trani
Department Name
General Surgery
Principal Investigator Name
Enrico Restini
Principal Investigator Email
enrico.restini@aslbat.it
Contact Person Name
Enrico Restini
Contact Person Email
enrico.restini@aslbat.it
Site Name
Azienda Ulss n.3 Serenissima – Ospedale di Mirano
Department Name
U.O.C. General Surgery Mirano
Principal Investigator Name
Corrado Da Lio
Principal Investigator Email
corrado.dalio@aulss3.veneto.it
Contact Person Name
Corrado Da Lio
Contact Person Email
corrado.dalio@aulss3.veneto.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Colon - Rectal Oncological Surgery
Principal Investigator Name
Paolo Delrio
Principal Investigator Email
p.delrio@istitutotumori.na.it
Contact Person Name
Paolo Delrio
Contact Person Email
p.delrio@istitutotumori.na.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
S.SC Oncological and Breast Surgery
Principal Investigator Name
Carlo Cabula
Principal Investigator Email
carlo.cabula@aob.it
Contact Person Name
Carlo Cabula
Contact Person Email
carlo.cabula@aob.it

Sponsor

Primary sponsor

Full Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
BLEOMYCIN
Active Substance
BLEOMYCIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
15000 IU

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