rectal cancer rectal cancer
Conditions
Interventions
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 preope
Sponsors
Akiyoshi Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed diagnosis of adenocarcinoma of the rectum 2) = 1,500 /mm3 ii. Platelets >= 10*104 /mm3 iii. Hemoglobin >= 9.0 g/dL iv. Total bilirubin = 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieved cCR or near-cCR and underwent NOM | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTakashi Akiyoshi
Cancer Institute Hospital
Outcome results
None listed