Metastatic colorectal cancer Colorectal cancer
Conditions
Interventions
Step1: Confirmation of dosage of each drug (Oxaliplatin and Irinotecan)
i)Induction treatment
The following drugs will be administered in 3week/cycle for 6cycles (maximum 8cycle, if investigator requi
Sponsors
Tsuji Akihito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Obtaining informed consent prior to study-specific screening procedures 2.Histologically-confirmed colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer 3.Clinically-confirmed metastatic colorectal cancer 4.Age>=20 years at the time of informed consent 5.ECOG performance status (PS) of 0,1 6.Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT. 7.Untreated metastatic colorectal cancer. Patients who underwent to adjuvant chemotherapy can be enrolled after 24 weeks from last administration. 8.RAS / BRAF testing was performed and confirmed RAS / BRAF wild type or mutation type 9.Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) i. Neutrophil count: >= 1200/mm3 ii. Platelet count: >= 10.0 x 104/mm3 iii. Hemoglobin: >= 9.0 g/dL iv. Total bilirubin: =30 ml/min vii. Protein Urea: == 3+, UPC (Urine protein / creatinine ratio: < 2.0) 10.Confirmed UGT1A1 wild type or UGT1A1 single hetero type
Exclusion criteria
Exclusion criteria: 1.Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field. 2.Untreated brain metastases or spinal cord compression or primary brain tumors. 3.History of CNS disease.(except for asymptomatic lacunar stroke) 4.Requiring chronic systemic corticosteroid treatment. 5.Patients who have uncontrolled anticoagulant therapy. 6.History / Presence of thrombosis within 1 year requiring medication. 7.Previously participated in any clinical trials and treatment with any investigational drug within 28 days. 8.Patient with i) Uncontrolled hypertension, ii) Uncontrolled diabetes, iii) Uncontrolled diarrhea, iv) >grade 1 peripheral neuropathy, v) Active peptic ulcer, vi) Non-healing wound (except for central venous port), vii) Clinically significant cardiovascular disease (for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication), viii) Uncontrolled venous thromboembolism, xi) Evidence or requiring systemic treatment for Infectious disease, x) Clinically important diseases. 9.Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure. (except for central venous port) 10.Lack of physical integrity of the upper gastrointestinal tract. 11.Pregnant women, lactating woman, positive by pregnancy test, wishing to become pregnant, and Sexually active males. 12.Hepatitis B or hepatitis C or Evidence of HIV infection. 13.History / Presence of paralytic ileus, obstruction or gastrointestinal perforation. 14.Other active co-existing malignancies. 15.History / Presence of paralytic ileus, obstruction or gastrointestinal perforation. 16.With massive pleural effusion or ascites 17.History of allergy to the drug of fluorouracil, oxaliplatin, irinotecan, bevacizumab and Chinese hamster ovary cell proteins of any components of the study medications. 18.History of fluoropyrimidine severe side effects caused by DPD defect. 19.Patients who underwent colonic stent. 20.Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) Overall survival (OS) Safety (Adverse event:Type, Grade) Patient reported outcome assessment (FACT/GOG-Ntx4) | — |
Contacts
Public ContactAkihito Tsuji
Kagawa University Hospital
Outcome results
None listed