2024-519007-10-00RecruitingPhase 2/3
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 29 Nov 2024
- Start date
- 22 Oct 2020
- Lead sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Diseases
- Colorectal cancer
- EU CT number
- 2024-519007-10-00
- EudraCT number
- 2018-004385-34
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 340
- 27 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.
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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano | Aviano | Italy | Recruiting |
| Istituto Tumori Bari Giovanni Paolo II | Bari | Italy | Recruiting |
| Sant Andrea Hospital | La Spezia | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Cagliari | Monserrato | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Italy | Recruiting |
| Istituto Oncologico Veneto | Padova | Italy | Recruiting |
| Casa Di Cura Macchiarella S.p.A. | Palermo | Italy | Recruiting |
| Azienda Sanitaria Locale TO3 | Pinerolo | Italy | Recruiting |
| Azienda Sanitaria Locale Della Provincia Di Biella | Ponderano | Italy | Recruiting |
| Azienda Ospedaliera Regionale San Carlo | Potenza | Italy | Recruiting |
| Ospedale ' Civile Maria Paterno' Arezzo | Ragusa | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
| Ospedale Isola Tiberina - Gemelli Isola | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario | Sondrio | Italy | Recruiting |
| Ospedale S.G. Moscati | Statte | Italy | Recruiting |
| Ospedale San Vincenzo Taormina | Taormina (Italy) | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Di Bergamo Ovest | Treviglio | Italy | Recruiting |
| Ospedale San Giovanni Bosco | Turin | Italy | Recruiting |
| Ospedale Santa Maria della Misericordia | Udine | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.