OncoMatch/Clinical Trials/NCT04095299
Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Is NCT04095299 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Capecitabine 825 mg/m2 twice daily on weekdays for cancer of rectum.
Treatment: Capecitabine 825 mg/m2 twice daily on weekdays — In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level. The aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.
Check if I qualifyExtracted eligibility criteria
Disease stage
Excluded: Stage CM1
Clinical tumor category cT1-3; Distant metastases verified by imaging or biopsy, i.e. cM1 [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: surgical treatment of the present cancer
Previous surgical treatment of the present cancer, including transanal excision of tumor
Cannot have received: radiation therapy
Exception: previous radiation treatment of the pelvis
Previous radiation treatment of the pelvis
Lab requirements
Blood counts
neutrophils ≥ 1.5 x 10^9/l and thrombocytes ≥ 100 x 10^9/l
Kidney function
serum creatinine < 1.5 x upper limit of normal or measured gfr > 30 ml/min
Liver function
alat < 2.5 x upper limit of normal, bilirubin < 2.5 x upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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