Rectal Cancer
Conditions
Interventions
None listed
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed colorectal adenocarcinoma 2.FOLFOXIRI as first-line 3.The lower margin of the tumor located between Rb and P 4.Clinical T4b or CRM positive by CT or MRI 5.M0 or M1 expected to be convertible with treatment 6.Age:20-80 years old 7.ECOG performance status 0-1 8.No prior chemotherapy or treatment such as rectal resection, pelvic lymph node dissection, or pelvic irradiation for any malignancies 9.Main organ function is maintained 10.Signed informed consent
Exclusion criteria
Exclusion criteria: 1.Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 2.Active infections, including HBs antigen positive 3.Body temperature >= 38 degrees Celsius 4.Serious complications 5.Currently treated with systemic steroids or immunosuppressive agents 6.Not appropriate for the trial by other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion Rate (R0 and R1 resection rate ) | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate Response rate Pathological response rate Surgical morbidity and complications The rate of early toxicity of neoadjuvant treatment Relapse-free survival Local relapse-free survival Negative Circumferential Resection Margin | — |
Countries
Japan
Contacts
Public ContactNobuhiro Sugano
Kanagawa Cancer Center Department of Gastrointestinal Surgery
Outcome results
None listed