NCT07483060Not yet recruitingPhase 4
Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer
Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 12 Mar 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Colorectal cancer
- NCT number
- NCT07483060
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 90
- From 12 Mar 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No residual luminal tumor following prior endoscopic resection
- Prior pelvic radiotherapy
- Concomitant medication contraindicated with capecitabine that cannot be safely discontinued
Other illness
- MRI-defined N1 or higher nodal disease
- Recurrent rectal cancer
- Known Gilbert's syndrome
Age
- Age \<18 years
Other
- Distant metastases (M1)
- MRI extramural vascular invasion (mriEMVI)
- Threatened mesorectal fascia (≤1 mm on MRI)
- Maximum tumor diameter \> 40 mm
- MRI defined mucinous tumor
- Uncontrolled significant cardiorespiratory comorbidity
- Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.