Rectal cancer Rectal cancer
Conditions
Interventions
Induction and consolidation chemotherapy:
Oxaliplatin 130mg/sqm over 2 hours, day1.
Capecitaine according to the body surface area (refer to the following) twice daily days1-15 every 3 weeks. Repeat
Chemotherapy, Radiotherapy, Adjuvant
Induction chemotherapy, Radiotherapy, Consolidation chemotherapy
Sponsors
Miura Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed rectal adenocarcinoma. 2) Tumor lower margin is located at rectum (RS, Ra, Rb, P). 3) High-resolution MRI scan is available and any of the following factors are present. Lateral lymph node metastasis, positive CRM, cT4, positive EMVI. 4) No distant metastasis. 5) Eastern Cooperative Oncology Group performance status (PS) 0-1. 6) Age at enrollment must be 20 years or older. 7) Adequate hematological, hepatic, renal and metabolic function parameters. 8) Written informed concent.
Exclusion criteria
Exclusion criteria: 1) Active multiple cancers (intraepithelial cancer is acceptable). 2) Contraindications to MRI (pacemaker, cerebral artery clipping, etc.) 3) Patients with myelosuppression (neutrophil count <1,500/mm3, platelet count <100,000/mm3). 4) Patients with severe renal impairment (Creatinine Clearance <30mL/min). 5) History of chemotherapy for the target disease. 6) Prior radiation therapy in the pelvic region. 7) Drug hypersensitivity to study medications. 8) History of major surgery (implantable central venous reservoir, stoma construction is acceptable) within 28 days prior to enrollment. 9) History of clinically serious cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment. 10) Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.). 11) Pregnant women, lactating women, and men who may be or intend to become pregnant, or whose partners wish to become pregnant. 12) Other patients who are judged by the study physician to be inappropriate for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, pCR rate, R0 rate, local recurrence rate, completion rate of preoperative treatment, incidence rate of adverse events, and incidence rate of surgical complications | — |
Contacts
Public ContactTakuya Miura
Hirosaki University Hospital
Outcome results
None listed