Unresectable advanced/metastatic colorectal cancer
Conditions
Interventions
Patients receive infusional oxaliplatin, bevacizumab, and oral TS-1 every 21 days.
Sponsors
Hiroshima Study group of Clinical Oncology (HiSCO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer (adenocarcinoma). 2) Clinically proven unresectable advanced/ metastatic colorectal cancer 3) 20 to 79 years of age 4) ECOG performance status 0-1 5) Presence of measurable lesion 6) No previous history of chemotherapy or radiotherapy for unresectable advanced/ metastatic colorectal cancer 7) Oral food intake possible 8) Adequate organ functions 9) Estimated life expectancy more than 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of serious drug hypersensitivity 2) Pregnant or possibly pregnant females, or males with female partners who are planning to pregnancy 3) Severe infectious disease 4) Severe comorbidity (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, uncontrollable hypertension, uncontrollable diabetes mellitus, etc) 5) Comorbidity or history of heart failure 6) Evidence of gastrointestinal ulcer or bleeding 7) Peripheral neuropathy 8) Wattery diarrhea 9) Massive pleural effusion or ascites 10) Clinical or radiological evidence of CNS metastases. 11) Current or previous (within the last 6 months) history of GI perforation 12) Previous history of thrombosis or cerebral infarction 13) Any surgical treatments within 28 days 14) Evidence of bleeding diathesis or coagulopathy 15) ongoing treatment with anticoagulant or aspirin (> 325mg/day) 16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 17) Previous history of adjuvant chemotherapy with oxaliplatin 18) Under coutinuous steroid administration 19) Any other serious or uncontrolled condition which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 20) Previous history of hemoptysis 21) Contraindication for administration of L-OHP, BV, TS-1, 5-FU, or l-LV 22) Presence of severe colorectal stricture 23) Radiological evidence of peritoneal dissemination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Incidence and degree of adverse events | — |
Countries
Japan
Contacts
Public ContactKobayashi Tsuyoshi
Hiroshima University Hospital Gasroenterological Surgery
Outcome results
None listed