Recurrent rectal cancer
Conditions
Interventions
1)KRAS wild-type: mFOLFOX6 + cetuximab 2)KRAS mutant-type: mFOLFOX6
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)A pelvic recurrence after rectal cancer surgery is proved histologically or diagnosed by an imaging 2)Resectable pelvic recurrence by pre-operative examination 3)No prior FOLFOX therapy 4) Patients with radiotherapy history are included 5) No evidence of distant metastasis 6)Age over 20 years 7)ECOG Performance Status (PS) 0-1 8)Written informed consent 9) Adequate organ function i)Leucocyte count: more than 3,000, less than 12,000 /mm3 ii)Platelet : more than 100,000 / mm3 iii)Serum total bilirubin : less than 1.5 mg / dl iv)AST : less than 100 U/l v) ALT : less than 100 U/l vi)Serum creatinine : less tahn 1.2 mg / dl
Exclusion criteria
Exclusion criteria: 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval 2) Severe infectious disease 3) Patients who receive steroid continuously are excluded 4) Unstable angina or myocardial infarction within 6 months 5) Interstitial pneumonia or fibroid lung 6) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 7) Those considered inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival Overall survival Safety Response rate Histological Response | — |
Countries
Japan
Contacts
Public ContactAkihiro Kobayashi
National Cancer Center Hospital East National Colorectal Surgery Division, Dept of Surgical Oncology
Outcome results
None listed