TOTAL NEOADJUVANT TREATMENT WITHOUT SURGERY FOR LOCALLY ADVANCED RECTAL CANCER: PROSPECTIVE CLINICAL TRIAL TO ASSESS TUMOR COMPLETE RESPONSE, CIRCULATING TUMOR GENETIC AND EPIGENETIC BIOMARKERS, AND STROMAL TRANSCRIPTOME TO INTERPRET CLINICAL OUTCOME (NO-CUT TRIAL)

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515225-28-00

Acronym

NO-CUT TRIAL

Enrollment

180

Registered

2024-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-05

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

Conditions

Adenocarcinoma of the medium/lower rectum in Stage II (cT3-4 N0) or Stage III (cT1-4, N1-2)

Brief summary

- Distant Relapse-Free Survival (DRFS) rate at 2.5 year - Association between 6-methylated gene panel and hazard ratio (HR) for relapse free survival - Association between ctDNA and relative hazard per standard deviation unit (HRσ) - Association between stromal score and odds ratio of response to treatment

Detailed description

- Clinical complete response rate - Local recurrence and organ preservation rate, colostomy-free survival - Overall survival - Patient reported outcomes (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 and its colorectal cancer specific module QLQ-38)

Interventions

DRUGOXALIPLATIN

DRUGCAPECITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
- Distant Relapse-Free Survival (DRFS) rate at 2.5 year - Association between 6-methylated gene panel and hazard ratio (HR) for relapse free survival - Association between ctDNA and relative hazard per standard deviation unit (HRσ) - Association between stromal score and odds ratio of response to treatment	—

Secondary

Measure	Time frame
- Clinical complete response rate - Local recurrence and organ preservation rate, colostomy-free survival - Overall survival - Patient reported outcomes (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 and its colorectal cancer specific module QLQ-38)	—

Countries

Italy

Outcome results

None listed

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