Rectal cancer
Conditions
Interventions
Perioperative chemotherapy with XELOX, preoperative 4 cycles followed by postoperative 4 cycles
Sponsors
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) >=20years-old <=75 years-old 3) ECOG performance status 0-1 4) Recral cancer(Ra, Rb) 5) Clinical stage T3 or T4 and/or lymph node positive. 6) No prior chemotherapy or radiotherapy 7) Adequate organ function
Exclusion criteria
Exclusion criteria: 1) Need to drain malignant coelomic fluid. 2) With distant metastases 3) Multiple primary cancer within 5years 4) Symptomatic or asymptomatic but treated heart disease 5) History of the serious hypersensitivity for Fluorouracil, platinum compound and levofolinate calcium 6) History of adverse events related to DPD loss 7) Uncontrolled Diarrhea 8) Peripheral neuropathy(Grade1<=) 9) Uncontrolled infection 10) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 11) No intention to practice birth control 12) Previously treated with oxaliplatin 13) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation rate, Safety, Down staging rate, Pathological complete response rate, Pathological effect, 2 year local recarence rate | — |
Countries
Japan
Contacts
Public ContactTsunekazu Mizushima
Osaka University Graduate School of Medicine Gastroenterological Surgery
Outcome results
None listed