Overview
Sponsor-declared trial summary
colorectal cancer
Evaluation of the safety and feasibility of the procedure and of the 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.
Key facts
- Sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-01-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519050-37-00
- EudraCT number
- 2018-004166-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
Evaluation of the safety and feasibility of the procedure and of the 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.
Conditions and MedDRA coding
colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10038038 | Rectal cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Male or female patients aged ≥18 years
- Histological confirmation of rectal adenocarcinoma
- Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment
- Rectal tumor up to 12 cm from the external anal margin
- Patients must be willing to comply with the study protocol and give their informed written consent.
- Patients with an ECOG status performance <3
Exclusion criteria 12
- Age less than 18 years
- Patients with neoplasia more than 12 cm from the anal margin
- Patients with stable disease or disease progression after neoadjuvant treatment
- Patients, who for medical reasons, cannot be given bleomycin
- Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
- Acute lung infection;
- Symptoms of poor lung function;
- Non correctable severe coagulation disorders;
- Previous allergic reactions to bleomycin;
- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;
- Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)
- Pregnancy or lactation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Evaluation of the safety and feasibility
- Increase in the rate of complete histopathological response in the treatment arm compared to the control arm.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP111064525 · ATC
- Active substance
- Bleomycin
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15000 IU international unit(s)
- Max total dose
- 15000 IU international unit(s)
- Max treatment duration
- 1000 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Sponsor organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Address
- Via Mariano Semmola 52
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Paolo Delrio
Public contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Paolo Delrio
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 70 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocollo versione 1_1 del 14 Apr 2020_Red | 1.1 |
| Recruitment arrangements (for publication) | Blank Document | 1 |
| Subject information and informed consent form (for publication) | Consenso al trattamento dei dati versione 1_1 del 14 Apr 2020 | 1.1 |
| Subject information and informed consent form (for publication) | Consenso informato versione 1_1 del 14 Apr 2020 | 1.1 |
| Subject information and informed consent form (for publication) | Lettera al medico di medicina generale v1 del 23 Feb 2021 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_Bleoprim | 1 |
| Synopsis of the protocol (for publication) | Sinossi versione 1_1 del 14 Feb 2020_Red | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-27 | Italy | Acceptable 2024-12-20
|
2025-01-10 |