locally advanced rectal cancer
Conditions
Interventions
Neo-adjuvant chemotherapy : XELOXIRI with Cetuximab 4 cycles Resection : total mesorectal excision or tumor-specific mesorectal excision Adjuvant chemotherapy : XELOX 4 cycles
Sponsors
Sapporo Medical University School of Medicine Department of Surgery, Surgical Oncology and Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 2) Histological confirmation of colorectal cancer. 3) Main lesion of the tumor is located at the Ra or Rb. 4) Lower edge of the tumor is within 12cm from anal verge. 5) Clinical stage T3 or T4, and/or lymph node positive. 6) RAS wild status 7) UGT1A1 *28 and *6 with wild type or heterotypes 8) Vital organ functions listed below are preserved within 2 weeks prior to entry. 1. WBC 4,000 /mm3 and over 2. Hemoglobin 9.0 g/dl and over 3. Platelet 100,000 /mm3 and over 4. Total bilirubin 1.5 ml/dl and less 6. AST and ALT 150 IU/l and less 7. Creatinine 1.5 mg/dl and less
Exclusion criteria
Exclusion criteria: 1) Any major surgical treatments within 4 weeks. 2) Prior chemotherapy or radiotherapy. 3) Pulmonary fibrosis or interstitial pneumonia. 4) Watery stool or diarrhea. 5) Active infection and inflammation or HBs antigen positive. 6) uncontrollable heart failure, renal failure, peptic ulcer, intestinal paralysis, ileus and diabetes mellitus. 7) synchronous or metachronous (within 3 years) malignancy other than carcinoma in situ 8) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. Men with no intention to practice birth control. 9) Severe mental disease. 10) History of the severe hypersensitivity. 11) Patients homozygous for UGT1A1*28, or UGT1A1*6, or heterozygous for both UGT1A1*28 and UGT1A1*6. 12) CTCAE v4.0>Grade1 of peripheral neuropathy. 13) Inadequate physical condition, as diagnosed by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Phase I To determine the recommended dose 2) Phase II pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year disease free survival 3 year local recurrence rate R0 resection rate Safety Pathological effect | — |
Countries
Japan
Contacts
Public ContactKenji Okita
Sapporo Medical University School of Medicine Department of Surgery, Surgical Oncology and Science
Outcome results
None listed