Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (NCT02394795) | Clinical Trial Compass
CompletedPhase 3
Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
Japan823 participantsStarted 2015-05-29
Plain-language summary
The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.
Who can participate
Age range20 Years ā 79 Years
SexALL
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Inclusion criteria
ā. Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.
ā. Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
ā. Aged ā„20 to \<80 years at the time of informed consent
ā. Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
ā. Patients with lesion(s) that can be evaluated. It is not essential to be evaluated the tumor according to the RECIST ver. 1.1.
ā. Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 24 weeks (168 days) after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. Patients who have received perioperative adjuvant chemotherapy including oxaliplatin are excluded.
ā. Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing. KRAS/NRAS test will be performed using the in vitro diagnostic listed in the National Health Insurance.
ā. Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment
Exclusion criteria
ā. Radiotherapy received within 4 weeks (28 days) prior to enrollment. Treatments aimed at relieving pain for bone metastases are excluded.
ā. Known brain metastasis or strongly suspected of brain metastasis
ā. Synchronous cancers or metachronous cancers with a disease-free period of ā¤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
ā. Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
ā. Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy