OncoMatch/Clinical Trials/NCT03671252
Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
Is NCT03671252 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including FOLFOXIRI and XELOX for rectal cancer.
Treatment: FOLFOXIRI · XELOX — Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Most importantly,chemoradiotherapy significantly increased surgical complication and poor long-term quality of life .In the absence of effective measures of predicting chemo-sensitivity, there is considerable risk of using any two-drug regimen for neoadjuvant therapy. Simultaneous use of the three chemotherapeutic drugs may be able to reduce the likelihood of resistance to both dual drug regimen and single drug regimen. The purpose of this study is to compare the efficacy and safety of three chemotherapeutic regimen known as FOLFOXIRI (the drug 5-fluorouracil, oxaliplatin, Irinotecan) with standard radiotherapy combined with capecitabine in neoadjuvant therapy for local advanced rectal cancer. The drugs in the FOLFOXIRI regimen are all FDA(Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: rectal surgery
Patients did not previously receive rectal surgery
Cannot have received: chemotherapy
Patients did not previously receive...chemotherapy
Cannot have received: radiation therapy
Patients did not previously receive...radiation therapy
Cannot have received: biological treatment
Patients did not previously receive...biological treatment
Cannot have received: pelvic or abdominal radiotherapy
History of pelvic or abdominal radiotherapy
Lab requirements
Blood counts
white blood cell count > 4000/mm3; Platelet count > 100000/mm3; Hemoglobin > 10 g/dL
Kidney function
Creatinine < 1.8 mg/dL
Liver function
SGOT and SGPT < 1.5 upper limit of normal (ULN); Bilirubin < 1.5 mg/dL
Laboratory values: Hematology: white blood cell count >4000/mm3; Platelet count >100000/mm3; Hemoglobin >10g/dL; Liver function: SGOT and SGPT < 1.5 upper limit of normal(ULN); Bilirubin< 1.5mg/dL; Renal function :Creatinine <1.8mg/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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