drugset / Trial / NCT07483060
Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer
Phase 4
Not yet recruiting
90 enrolled
Vastra Gotaland Region
Skane University Hospital · collabStockholm South General Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-03-12
- Primary completion
- 2028-12-31
- Completion
- 2031-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |