Taking people in ItalyPhase 2/3
Tests aspirin and metformin with chemotherapy before rectal cancer surgery
Tests aspirin, metformin, or both alongside chemotherapy in adults with locally advanced rectal cancer.
Key facts
- Who runs it
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- 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, and Udine, ItalySee the 27 sites
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 340 people, planned
- Started
- 22 Oct 2020
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Record updated
- 16 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. 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 locally advanced rectal cancer (stage II or III) who can have chemotherapy, chemoradiotherapy and surgery. It tests aspirin, metformin or both added to treatment before surgery.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Adenocarcinoma of the rectum proven by biopsy within 56 days before randomisation; locally advanced, TNM stage II or III.
- Earlier treatment
- No earlier treatment for locally advanced rectal cancer and no earlier pelvic radiotherapy. No daily aspirin and/or metformin for more than 4 weeks before randomisation.
Main reasons for not taking part
- Recurrent rectal tumour
- Clear evidence of metastatic disease (unclear lesions are allowed)
- Taking daily aspirin and/or metformin for more than 4 weeks before randomisation
- Allergy to salicylic acid compounds or prostaglandin synthetase inhibitors
- Allergy to metformin
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- Centro di Riferimento Oncologico di AvianoAviano, ItalyTaking people
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- Sant Andrea HospitalLa Spezia, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di CagliariMonserrato, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Casa Di Cura Macchiarella S.p.A.Palermo, ItalyTaking people
- Azienda Sanitaria Locale TO3Pinerolo, ItalyTaking people
- Azienda Sanitaria Locale Della Provincia Di BiellaPonderano, ItalyTaking people
- Azienda Ospedaliera Regionale San CarloPotenza, ItalyTaking people
- Ospedale ' Civile Maria Paterno' ArezzoRagusa, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Ospedale Isola Tiberina - Gemelli IsolaRome, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto LarioSondrio, ItalyTaking people
- Ospedale S.G. MoscatiStatte, ItalyTaking people
- Ospedale San Vincenzo TaorminaTaormina (Italy), ItalyTaking people
- Azienda Socio Sanitaria Territoriale Di Bergamo OvestTreviglio, ItalyTaking people
- Ospedale San Giovanni BoscoTurin, ItalyTaking people
- Ospedale Santa Maria della MisericordiaUdine, ItalyTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests aspirin and metformin with chemotherapy before rectal cancer surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 16 September 2026