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 (Jun 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
Treatments studied
Chemotherapy
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.
Frequently asked questions
Is NCT04095299 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior surgical treatment of the present cancer, radiation therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify