rectal cancer rectal cancer
Conditions
Interventions
arm A:Preoperative CRT(28*1.8 Gy+Capecitabine 825mg/m2 bid, day 1-5, 8-12, 15-19, 22-26, 29-33, 36-38)+consolidation chemotherapy(CapeOX 6 courses: Capecitabine 2000mg/m2/day, d1-14, Oxaliplatin 130mg
Sponsors
Akiyoshi Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed diagnosis of adenocarcinoma of the rectum 2) = 20 years 6) Adequate organ functions within 28 days prior to entry i. Neutrophils >= 1,500 /mm3 ii. Platelets >= 10*104 /mm3 iii. Hemoglobin >= 9.0 g/dL iv. Total bilirubin = 60 mL/min/body vii. Urine protein/creatinine < 1 7) If there is bowel obstruction or strong stricture, stoma construction prior to neoadjuvant therapy 8) 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) Administration contraindication of capecitabine, oxaliplatin, or bevacizumab 4) Uncontrolled active infection 5) Fever 38.0 >= degree celsius at entry 6) Possible pregnant or pregnant or nursing female 7) Patients with concurrent psychiatric condition or disease which would make them inappropriate candidates for entry into this study in the investigator's judgement 8) Patients with concurrent serious complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, hypertension, thrombotic disease, gastrointestinal fistula, etc) 9) History of operation <= 4 weeks or minor operation such as stoma construction <= 2 weeks 10) Deficient mismatch repair (dMMR) determined by immunohistochemistry and/or MSI testing using pre-treatment biopsy specimens 11) Other conditions not suitable for this study in the investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pCR and cCR >= 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical complete response rate, Near-clinical complete response rate, Rate of non-operative management, 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