NeoAspMet - Neoadjuvant Aspirin and/or Metformin during preoperative induction chemotherapy and chemoradiotherapy for locally-advanced rectal cancer. A multi-arm, multi-stage, intergroup (STAR-04/SICO-CR01/GISCAD/AIRO-GI) randomised clinical trial. The NeoAspMet trial
Key facts
- Where
- Aviano, Bari, La Spezia, Milan, Modena, Monserrato, Monza, Naples, Novara, Orbassano, Padova, Palermo, Pinerolo, Ponderano, Potenza, Ragusa, Reggio Emilia, Rome, Sondrio, Statte, Taormina (Italy), Treviglio, Turin és Udine, OlaszországSee the 27 sites
- Phase
- 2/3. fázis
Where in Olaszország
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországTaking people
- Istituto Tumori Bari Giovanni Paolo IIBari, OlaszországTaking people
- Sant Andrea HospitalLa Spezia, OlaszországTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországTaking people
- Ospedale San Raffaele S.r.l.Milan, OlaszországTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországTaking people
- Azienda Ospedaliero-Universitaria Di CagliariMonserrato, OlaszországTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, OlaszországTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, OlaszországTaking people
- Istituto Oncologico VenetoPadova, OlaszországTaking people
- Casa Di Cura Macchiarella S.p.A.Palermo, OlaszországTaking people
- Azienda Sanitaria Locale TO3Pinerolo, OlaszországTaking people
- Azienda Sanitaria Locale Della Provincia Di BiellaPonderano, OlaszországTaking people
- Azienda Ospedaliera Regionale San CarloPotenza, OlaszországTaking people
- Ospedale ' Civile Maria Paterno' ArezzoRagusa, OlaszországTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, OlaszországTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországTaking people
- Ospedale Isola Tiberina - Gemelli IsolaRome, OlaszországTaking people
- Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto LarioSondrio, OlaszországTaking people
- Ospedale S.G. MoscatiStatte, OlaszországTaking people
- Ospedale San Vincenzo TaorminaTaormina (Italy), OlaszországTaking people
- Azienda Socio Sanitaria Territoriale Di Bergamo OvestTreviglio, OlaszországTaking people
- Ospedale San Giovanni BoscoTurin, OlaszországTaking people
- Ospedale Santa Maria della MisericordiaUdine, OlaszországTaking people
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 2024-519007-10-00
- Record updated
- 2026. szeptember 16.
- Original description
Primary objective is to assess the effect of each of the 3 experimental interventions (aspirin, metformin or both, in combination with neoadjuvant induction chemotherapy (ICT) and preoperative chemoradiation (CRT)) compared to standard neoadjuvant ICT followed by preoperative CRT on Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage.Read full original descriptionShow less
Primary objective is to assess the effect of each of the 3 experimental interventions (aspirin, metformin or both, in combination with neoadjuvant induction chemotherapy (ICT) and preoperative chemoradiation (CRT)) compared to standard neoadjuvant ICT followed by preoperative CRT on Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage.
Inclusion: Pathologically proven diagnosis of adenocarcinoma of the rectum by endoscopic biopsy within 56 days prior to randomisation. Locally advanced tumour (defined as TNM Stage II or III) based upon the following minimum diagnostic workup: MRI of the pelvis, contrast-enhanced CT of abdomen and chest. Able to undergo induction chemotherapy, chemoradiotherapy and total mesorectal excision (TME). For further information please refer to the protocol.
Exclusion: Prior treatment for LARC (recurrent rectal tumours are excluded) or previous pelvic radiotherapy. Unequivocal evidence of established metastatic disease based on minimum diagnostic workup. Patients with equivocal lesions are eligible. Patients already taking daily aspirin and/or metformin for more than 4 weeks prior to randomisation. Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors and to any of the excipients. Hypersensitivity to metformin or to any of the excipients. For further information please see protocol.