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

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Written informed consent

Biopsy-proven rectal adenocarcinoma

Tumor located <12 cm from the anal verge

Disqualifiers

MRI-defined N1 or higher nodal disease

Distant metastases (M1)

MRI extramural vascular invasion (mriEMVI)

Threatened mesorectal fascia (≤1 mm on MRI)

Trial design

Treatments tested in this trial

  • Capecitabine + Radiotherapy
  • Total Mesorectal Excision (TME)

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Vastra Gotaland Region

Lead sponsor

Skane University Hospital

Collaborator

Stockholm South General Hospital

Collaborator