Rectal cancer
Conditions
Interventions
Preoperative short radiotherapy+chemotherapy+surgery+-adjuvant chemotherapy
Sponsors
Matsuda Takeru
Kakeji Yoshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven adenocarcinoma of the rectum 2) Lower margin of tumor within 12 cm from anal verge (AV) 3) cT2N1~3M0 or cT3~4bNanyM0 by diagnostic imaging 4) The presence or absence of clinical metastasis of the lateral pelvic lymph nodes is irrelevant. 5) Negative for clinical inguinal lymph node metastasis. 6) Age at the time of registration is over 20 years old. 7) Performance Status (PS) is 0 or 1. 8) Major organ function is preserved by clinical examination within 14 days before registration (examination on the same day of the week 2 weeks before the registration date is acceptable) (examination to determine whether the patient is eligible for this study may adopt the results of tests performed before obtaining informed consent as general tests for cancer treatment). 1. Neutrophil count >=1,500/mm3 2. Platelet count >=100,000 /mm3 3. Hemoglobin >=8.0 g/dL 4. AST, ALT <=100 IU/L 5. Total bilirubin <=1.5 mg/dL 6. Serum creatinine <=1.5 mg/dL 9) Patients who have given their voluntary written consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: (1) Have received anticancer drug therapy, radiation therapy, hormone therapy, or immunotherapy within 4 weeks before registration (2) Have allergy to drugs used in this study (3) Have an active infection which requires systemic treatment (4) Serious comorbidities (heart failure, ischemic heart disease, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes mellitus, severe paresthesia or paresthesia with functional impairment,etc.). (5) Severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.). (6) History of clinically relevant psychiatric disorder or central nervous system disorder. (7) Gastrointestinal perforation, active gastrointestinal ulcer, CTCAE (ver5.0) Grade 3 or higher bleeding (site not specified). (8) Active double cancer. (Synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to be cured by local treatment are excluded from this criteria.) (9) HBs antigen positive or HCV antibody positive. (10) Pregnant women, breastfeeding women, or women who may be pregnant (11) Patients who are judged inappropriate for participation in this clinical study by the principal investigator or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcome: Overall survival, recurrence-free survival, R0 resection rate, histological response rate Safety outcome: rate of preoperative treatment-related disease, rate of protocol treatment completion, rate of preoperative radiotherapy completion, rate of preoperative chemotherapy completion, rate of intraoperative complications, rate of postoperative complication | — |
Contacts
Public ContactOtowa Yasunori
Kobe University Hospital
Outcome results
None listed