Rectal cancer
Conditions
Interventions
S-1:80mg/m2 day1-14, 22-35 CPT-11:Level 1 100mg/m2, Level 2 125mg/m2, Level 3 150mg/m2 day1, 22 Cetuximab:400mg/m2 day-7, 250mg/m2 day1, 8, 15, 22, 29, 36 Radiation:1.8 Gy of consecutive 5 days, to
Sponsors
Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: T3-T4 low rectal cancer Wild type K-ras was observed in DNA analysis.
Exclusion criteria
Exclusion criteria: Patients were excluded if they had prior RT to the pelvic region or previous cytotoxic chemotherapy or if they had other synchronous cancers. Patients suffering from the following conditions were also ineligible: inflammatory bowel disease, malabsorption syndrome, ischemic heart disease, peripheral neuropathy, and psychiatric disorders or psychologic disabilities thought to adversely affect treatment compliance. In addition, pregnant or lactating patients and women with childbearing potential who lacked effective contraception were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities (DLTs) Complication rate R0 resection rate downstaging rate | — |
Countries
Japan
Contacts
Public ContactMitsuyoshi Ota
Yokohama City University Graduate School of Medicine Gastroenterological surgery
Outcome results
None listed