OncoMatch/Clinical Trials/NCT06205485
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Is NCT06205485 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Leucovorin and Oxaliplatin for rectal cancer.
Treatment: Leucovorin · Oxaliplatin · Fluoruracil · Capecitabine — This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
mismatch repair proficient
Excluded: DPYD dihydropyrimidine dehydrogenase deficiency
Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD) [excluded].
Disease stage
Required: Stage CT1 NOT ELIGIBLE FOR TRANSANAL SURGERY, CT3A, CT3B, CN0 (MRI and CT)
Excluded: Stage HIGH HISTOLOGIC GRADE (POORLY DIFFERENTIATED), T3 TUMOURS INVADING OR ABUTTING THE INTERNAL SPHINCTER
Grade: well-differentiatedmoderately differentiated
MRI stage cT1 not eligible for transanal surgery or cT2-T3ab; cN0 stage based on pelvic MRI; M0 stage based on no evidence of metastatic disease by CT imaging
Performance status
ECOG OR KARNOFSKY 0–1
Patient must have an ECOG performance of <2 (or Karnofsty ≥ 60%).
Prior therapy
Cannot have received: pelvic radiation
Cannot have received: treatment for rectal cancer
Lab requirements
Blood counts
ANC ≥ x 10^9/L; platelet count ≥ 100 x 10^9/L
Kidney function
Estimated creatinine clearance of ≥ 50ml/min
Liver function
bilirubin < 1.5 UNL, excluding Gilbert's syndrome
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Adequate normal organ and marrow function: ANC ≥ x 10^9/L; platelet count ≥ 100 x 10^9/L; bilirubin < 1.5 UNL, excluding Gilbert's syndrome; Estimated creatinine clearance of ≥ 50ml/min. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cancer Center at Saint Joseph's · Phoenix, Arizona
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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