Next Generation StaR TREC - Save the rectum by watchful waiting after (chemo)Radiotherapy or Total mesorectal excision for early REctal Cancer?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522955-25-00

Enrollment

Registered

2026-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-09

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

Conditions

Rectal cancer

Brief summary

Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.

Detailed description

Local recurrence, Local regrowth, Survival (overall), Metastases, Organ preservation rate, Clinical complete response rate, Morbidity measured with Comprehensive Complications Classification Index (41), Total length of hospital stay, Radical resection (R0) after surgery, Urinary function, Sexual function, Bowel function, Presence of a stoma

Interventions

DRUGCapecitabine Orion 500 mg filmdragerade tabletter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Local recurrence, Local regrowth, Survival (overall), Metastases, Organ preservation rate, Clinical complete response rate, Morbidity measured with Comprehensive Complications Classification Index (41), Total length of hospital stay, Radical resection (R0) after surgery, Urinary function, Sexual function, Bowel function, Presence of a stoma	—

Primary

Measure	Time frame
Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.	—

Countries

Sweden

Outcome results

None listed

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