2024-519050-37-00Not yet recruitingPhase 2
ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY - LARC_ DEEP_CANCERS
ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY - LARC_ DEEP_CANCERS
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 27 Nov 2024
- Start date
- 1 Jan 2019
- Lead sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Diseases
- Colorectal cancer
- EU CT number
- 2024-519050-37-00
- EudraCT number
- 2018-004166-33
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rectal cancer (adenocarcinoma) who had a major response to treatment given before surgery. They would receive electrochemotherapy, with the aim of sparing the rectum.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Locally advanced rectal adenocarcinoma, tumour up to 12 cm from the outer edge of the anus, with a confirmed major clinical response after treatment given before surgery
- Earlier treatment
- Must have had treatment for locally advanced rectal cancer before surgery (neoadjuvant treatment). Total earlier bleomycin dose must not have passed 250 mg/m2.
Main reasons for not taking part
- Stable disease or disease growth after the treatment given before surgery
- Pregnancy or breastfeeding
- Cannot be given bleomycin, or had an allergic reaction to it before
- Lung infection, or signs of poor lung function
- Severe bleeding disorders that cannot be corrected
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;
- Previous allergic reactions to bleomycin;
Other illness
- Patients with stable disease or disease progression after neoadjuvant treatment
- Acute lung infection;
- Non correctable severe coagulation disorders;
Lab values
- Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)
Age
- Age less than 18 years
Other
- Pregnancy or lactation
- Patients with neoplasia more than 12 cm from the anal margin
- Patients, who for medical reasons, cannot be given bleomycin
- Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
- Symptoms of poor lung function;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Sanitaria Locale Della Provincia Di Barletta Andria Trani | Andria | Italy | Not yet recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi | Bologna | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Cagliari | Cagliari | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina | Messina | Italy | Not yet recruiting |
| Azienda Ulss n.3 Serenissima – Ospedale di Mirano | Mirano | Italy | Not yet recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Not yet recruiting |
| Fondazione PTV - POLICLINICO TOR VERGATA | Roma | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.