Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine + Radiotherapy | Combination Product | — | UNRESOLVED |
| Total Mesorectal Excision (TME) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mesorectal chemoradiotherapy
- description
- Participants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg/m² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured "watch and wait" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care.
- interventionNames
- Combination Product: Capecitabine + Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Standard Surgery (Total Mesorectal Excision)
- description
- Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available