The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting.

Not Applicable

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000027108
• Lead Sponsor: Department of Surgery, Jichi Medical University, Saitama Medical Center, 1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-01
• Study Completion: 2018-11-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1)History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection) 2)With massive pleural effusion or ascites requiring intervention 3)Radiological evidence of brain tumor or brain metastases 4)Active infection including hepatitis 5)Any of the following concurrent diseases: i.Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii.Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii.Interstitial pneumonia or pulmonary fibrosis iv.Uncontrolled diabetes mellitus v.Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy) 6)Any of the following medical history: i.Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes ii.Serious hypersensitivity to any of the study drugs iii.History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency 7)Previous treatment with irinotecan hydrochloride 8)Current treatment with atazanavir sulfate 9)Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment 10)Pregnant or lactating females, and males and females unwilling to use contraception

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR) Disease Control Rate (DCR) Overall survival (OS) Safety