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

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519007-10-00

Enrollment

340

Registered

2025-01-10

Start date

2020-10-22

Completion date

Unknown

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced stage II/III rectal cancer

Brief summary

Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage

Detailed description

Tumor Regression Rate Pathological complete responses (pCR) NeoAdjuvant Rectal (NAR) score MRI Tumor Downstaging (mr TGR) rate Event-Free Survival (EFS) Overall Survival (OS) Time to Distant Recurrence (TDR) Rate of local recurrence at 3 years Abdominal Perineal Resection (APR) rate Organ preservation rate at 3 years Post-operative complications Treatment-related toxicity Quality of Life (QoL). For further information please see protocol

Interventions

DRUGCAPECITABINE

DRUGMETFORMIN

DRUGACETYLSALICYLIC ACID

DRUGOXALIPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage	—

Secondary

Measure	Time frame
Tumor Regression Rate Pathological complete responses (pCR) NeoAdjuvant Rectal (NAR) score MRI Tumor Downstaging (mr TGR) rate Event-Free Survival (EFS) Overall Survival (OS) Time to Distant Recurrence (TDR) Rate of local recurrence at 3 years Abdominal Perineal Resection (APR) rate Organ preservation rate at 3 years Post-operative complications Treatment-related toxicity Quality of Life (QoL). For further information please see protocol	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026