T CORE2401: A randomized phase II study assessing the efficacy and safety of mFOLFOX6 + Cetuximab (q2w) and mFOLFOX6 + Bevacizumab as first-line treatment for RAS/BRAF wild-type metastatic right-sided colon cancer.
T CORE2401: A randomized phase II study assessing the efficacy and safety of mFOLFOX6 + Cetuximab (q2w) and mFOLFOX6 + Bevacizumab as first-line treatment for RAS/BRAF wild-type metastatic right-sided colon cancer.
Ishioka Chikashi
JR SENDAI HOSPITAL
1-1-5 itsutsubashi,Aoba-ku,Sendai,Miyagi,980-0022 Japan
+81-22-266-9671
chikashi@tohoku.ac.jp
Ishikawa Toru
Tohoku-Clinical Oncology Research and Educational Sociaty
(1) Histologically confirmed as adenocarcinoma of right-sided colon (caecum, ascending colon, transverse colon).
(2) Colon cancer with distant metastasis (Stage IV according to the UICC TNM classification) or colorectal cancer that has recurred after surgery.
(3) Patients who have not received chemotherapy for colorectal cancer. However, if adjuvant chemotherapy with fluoropyrimidine and oxaliplatin is administered before and after surgery, patients can be enrolled if recurrence is confirmed 24 weeks (168 days) or more after the start of the last administration.
(4) Patients who have been confirmed to be wild type for all RAS (KRAS, NRAS) tests.
(5) Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 or 1.
(6) Age: 20 years or older at the time of obtaining consent.
(7) Patients who can understand the consent document for this clinical research and who have provided written consent.
(8) Patients with the following bone marrow, liver, and renal functions based on data within 14 days prior to registration
a) Neutrophil countt: 1500/uL or more
b) Hemoglobin level: 9.0 g/dL or more
c) Platelet count: 10.0x104/uL or more
d) Total serum bilirubin: 2.0 mg/dL or less
e) Serum AST (GOT) and serum ALT (GPT): 100 U/L or less each (200 U/L or less if there is liver metastasis)
f) Serum creatinine:1.50 mg/dL or less
g) Prothrombin time-international normalized ratio (PT-INR) less than 1.5 (for patients taking warfarin, PT-INR less than 3.0)
h) Urine protein:at least one of the following
(i) Urine protein (urine dipstick test) of 1+ or less, (ii) Urine protein creatinine (UPC) ratio <- 1.0, (iii) Urine protein <-1000 mg/day as measured by 24-hour urine collection
(9) Cases in which at least one measurable target lesion (RECIST ver. 1.1 criteria).
(10) Cases in which survival of at least 3 months (90 days) is expected from the time of registration
(11) Cases in which the principal investigator or sub-investigator judges that treatment is possible according to this protocol.
(1) Confirmed BRAF V600E mutation.
(2) Patients who have undergone radiotherapy within 4 weeks (28 days) prior to registration.
(3) Patients with brain metastases or highly suspected brain metastases.
(4) Patients with synchronous or metachronous multiple cancers (excluding colorectal cancer) with a disease-free period of less than 5 years.
(5) Patients with body cavity fluid (pleural fluid, ascites, pericardial fluid, etc.) that requires treatment.
(6) Patients who are not willing to use contraception, pregnant women, lactating women, and women with a positive pregnancy test.
(7) Patients with an open surgical wound that has not healed.
(8) Patients with active bleeding requiring blood transfusion.
(9) Patients requiring systemic steroid administration for therapeutic purposes.
(10) Patients who have had an intestinal resection within 4 weeks (28 days) prior to registration.
(11) Patients with a history of interstitial lung disease (interstitial pneumonia, pulmonary fibrosis, etc.) or who have clearly extensive findings of these diseases on computerized tomography.
(12) Patients with unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or other arterial thromboembolism, or who have had such an event within 24 weeks (168 days) prior to registration (excluding asymptomatic lacunar infarction).
(13) Patients with a history of serious drug hypersensitivity.
(14) Patients with local or systemic active infection requiring treatment, or suspected infection.
(15) Patients with heart failure of New York Heart Association (NYHA) functional class II or higher, or with serious heart disease.
(16) Patients with paralytic ileus, gastrointestinal transit disorders, or uncontrolled diarrhea.
(17) Patients with poorly controlled hypertension.
(18) Patients with poorly controlled diabetes mellitus.
(19) Patients with active hepatitis B.
(20) Patients with known human immunodeficiency virus (HIV) infection.
(21) Patients with Grade 2 or higher peripheral neuropathy as assessed by the Japanese version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 of the JCOG.
(22) Patients who the principal investigator or sub-investigator deems unsuitable for participation in this clinical research.
(23) Confirmed to be MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficiency)
20age old exceed
No limit
Both
colorectal cancer
Right-sided colon cancer patients who have been registered will be randomly assigned to receive treatment in either the mFOLFOX6 + Cetuximab (q2w) group or the mFOLFOX6 + Bevacizumab group.
Response rate
Disease control rate,Overall survival,Progression free survival,Eearly tumor shrinkage,Deepness of Response,Resection rate,Adverse event
Tohoku-Clinical Oncology Research and Educational Sociaty
Tohoku Certified Review Board of Tohoku University
