Rectal Cancer
Conditions
Interventions
1. In the case of KRAS wild-type, 6 courses of mFOLFOX6+cetuximab is performed, followed by TME. 2. In the case of KRAS mutant-type, 6 courses of mFOLFOX6+bevacitumab is performed, followed by TME.
Sponsors
Gastro-intestinal Sugery Division, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: # Histologically confirmed adenocarcinoma of the rectum. # Main part of the tumor is located in rectum or anal canal. # Distal border of the tumor is located at or below peritoneal reflection. # cT3, N0, M0 or T1-3, N1, M0 disease as assessed by transrectal ultrasound, CT or MRI. # KRAS status is known. # ECOG PS 0-1. # Patient Characteristics: 1. WBC >= 3,000/mm3 2. ANC >= 1,500/mm3 3. Platelet count >= 100,000/mm3 4. Hemoglobin >= 9.0g/dL 5. Total bilirubin <= 1.5*ULN 6. AST <= 5*ULN 7. ALT <= 5*ULN 8. ALP <= 5*ULN 9. Serum creatinine <= 1.5*ULN # Informed consent is obtained.
Exclusion criteria
Exclusion criteria: # Distant metastases # Cerebrovascular disease (CVD) with paralytic symptoms or prior CVD within one year. # Symptomatic or actively treated cardiac disorders. Or prior cardiac disorder within one year. # Cancerous fluid on diagnostic imaging. # Prior chemotherapy or pelvic irradiation for malignancy. # Other cancer diagnosis within the past 5 years (including colorectal cancer). # Interstitial pneumonia or fibroid lung. # Uncontrolled infection. # Current symptoms of neuropathy, defined as >= grade 2 neurosensory or neuromotor toxicity. # Ileus (cases with diverting stoma are eligible). # Uncontrolled diarrhea. # Pregnant, nursing or no intention to contraception. # Contraindication for the administration of bevacitumab (In the cases of KRAS mutant-type) # Those considered inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS, RFS, OS, local recurrence rate, Incidence of (severe) adverse event, Incidence of postoperative morbidity, Incidence of sexual dysfunction (male only), Incidence of urinary and anal dysfunction, Clinical response, Relative dose intensity, Chemotherapy completion rate | — |
Countries
Japan
Contacts
Public ContactSuguru Hasegawa, MD
Kyoto University Hospital Gastro-intestinal Surgery
Outcome results
None listed