ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY - LARC_ DEEP_CANCERS
Key facts
- Where
- Andria, Bologna, Cagliari, Messina, Mirano, Naples és Roma, OlaszországSee the 7 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Sanitaria Locale Della Provincia Di Barletta Andria TraniAndria, OlaszországToborzás még nem indult
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola MalpighiBologna, OlaszországToborzás még nem indult
- Azienda Ospedaliero - Universitaria di CagliariCagliari, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, OlaszországToborzás még nem indult
- Azienda Ulss n.3 Serenissima – Ospedale di MiranoMirano, OlaszországToborzás még nem indult
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországToborzás még nem indult
- Fondazione PTV - POLICLINICO TOR VERGATARoma, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Trial code
- EU 2024-519050-37-00
- Record updated
- 2025. január 10.
- Original description
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.Read full original descriptionShow less
ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY - LARC_ DEEP_CANCERS
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.
Inclusion: 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: Previous cumulative dose of 250 mg/m2 of bleomycin exceeded; Previous allergic reactions to bleomycin; Patients with stable disease or disease progression after neoadjuvant treatment; Acute lung infection; Non correctable severe coagulation disorders; Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin); Age less than 18 years; 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.