NIPH Clinical Trials Search

Non-operative Management after Chemoradiotherapy plus Sandwich (Induction and Consolidation with modified FOLFOXIRI) Chemotherapy in Patients with Locally Advanced Rectal Cancer: Multicenter Phase II Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	rectal cancer
Date of first enrollment	07/01/2026
Target sample size	75
Countries of recruitment
Study type	Interventional
Intervention(s)	Induction chemotherapy (mFOLFOXIRI for 4 cycles: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, irinotecan 150 mg/m2, and fluorouracil 2400 mg/m2 over 46 hours, repeated every 2 weeks) followed by preoperative chemoradiotherapy (CRT) (28*1.8 Gy+Capecitabine 825mg/m2 bid, day 1-5, 8-12, 15-19, 22-26, 29-33, 36-38), followed by consolidation chemotherapy (mFOLFOXIRI for 4 cycles), and then surgery or non-operative management for cCR/near-cCR cases.

Outcome(s)

Primary Outcome

The proportion of patients who achieved cCR or near-cCR and underwent NOM

Secondary Outcome

Clinical complete response rate, Near-clinical complete response rate, Rate of pCR and cCR >= 2 years, Overall survival, Distant metastasis-free survival, Locoregional failure-free survival, Time to disease-related treatment failure, TME-free survival, Permanent stoma-free survival, Safety of the treatment, Completion rate of the treatment, Fecal incontinence according to Wexner Score and LARS-scale, Quality of life according to EORTC Quality of Life questionnaire - C30 and CR29, TME cases- Surgical morbidity, R0 resection rate, Pathological stage, Dworak tumor regression grade NOM cases- Local regrowth rate, Time to local regrowth, Salvage surgery rate in patients with local regrowth, Surgical morbidity in salvage surgery, R0 resection rate in salvage surgery

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include criteria	1) Histologically confirmed diagnosis of adenocarcinoma of the rectum 2) <= 5 cm from the anal verge or candidate for APR or intersphincteric resection prior to neoadjuvant therapy according to the primary surgeon 3) Clinical stage II (cT3-4N0) or stage III (cT3-4N1-3) by MRI and CT 4) ECOG PS 0 or 1 (for patients aged 70 years or older at the time of consent, PS must be 0) 5) Age between 18 and 75 years 6) Genetic testing of peripheral blood confirms the absence of UGT1A1 *6/*6, UGT1A1 *28/*28, or UGT1A1 *6/*28 genotypes 7) Adequate organ functions within 14 days prior to entry i. Neutrophils >= 1,500 /mm3 ii. Platelets >= 10*104 /mm3 iii. Hemoglobin >= 9.0 g/dL iv. Total bilirubin <= 1.5 mg/dL v. AST, ALT <= 100 IU/L vi. Serum creatinine <= 1.5 mg/dL or Ccr >= 60 mL/min/body 8) No obstruction or severe stenosis is present (the lower gastrointestinal endoscope can pass through the tumor site) 9) Written informed consent
Exclude criteria	1) Patients with a history of a prior malignancy within the past 5 years, except for adequately treated cancer with 5-year relative survival rate >= 95% 2) History of pelvic irradiation 3) Uncontrolled active infection 4) Fever 38.0 >= degree celsius at entry 5) Pregnant, possibly pregnant, or breastfeeding females, or male and female patients unwilling to use contraception 6) Patients with concurrent psychiatric condition or disease which would make them inappropriate candidates for entry into this study in the investigator's judgement 7) Patients with concurrent serious complication (heart failure, uncontrolled diabetes, renal failure, liver failure, hypertension, thrombotic disease, gastrointestinal fistula, etc) 8) Patients with severe pulmonary diseases (e.g., interstitial pneumonia, pulmonary fibrosis, or severe emphysema) 9) Patients with diarrhea (watery stools) that interferes with daily activities 10) Patients with a history of severe drug hypersensitivity or severe drug allergy 11) Patients who are positive for HBs antigen 12) Patients with a history of surgery, such as laparotomy, within the past 4 weeks 13) Deficient mismatch repair (dMMR) determined by immunohistochemistry and/or MSI testing using pre-treatment biopsy specimens 14) Other conditions not suitable for this study in the investigator's judgement