Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer

Starting soon · Phase 4

Conditions studied: Rectal Cancer

In brief

This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.

Key facts

Study ID

NCT07483060

Run by

Vastra Gotaland Region

People needed

90

Starts

2026-03-12

Expected to finish

2031-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Written informed consent
• Biopsy-proven rectal adenocarcinoma
• Tumor located <12 cm from the anal verge
• MRI-staged T1-T3b tumor
• N0 or NX (no radiologic evidence of nodal metastases)
• M0 or MX (no radiological evidence of distant metastases)
• ECOG performance status 0-1
• Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options

You may not qualify if…

• MRI-defined N1 or higher nodal disease
• Distant metastases (M1)
• MRI extramural vascular invasion (mriEMVI)
• Threatened mesorectal fascia (≤1 mm on MRI)
• Maximum tumor diameter > 40 mm
• MRI defined mucinous tumor
• No residual luminal tumor following prior endoscopic resection
• Recurrent rectal cancer
• Prior pelvic radiotherapy
• Uncontrolled significant cardiorespiratory comorbidity
• Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
• Known Gilbert's syndrome
• Pregnancy or breastfeeding
• Concomitant medication contraindicated with capecitabine that cannot be safely discontinued
• Age <18 years

Full record on ClinicalTrials.gov

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