Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer (NCT07483060) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer
90 participantsStarted 2026-03-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.