Randomized Phase II Study of Regorafenib followed by Cetuximab versus Reverse SequenCe for Wild-Type KRAS Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine, Oxaliplatin, and Irinotecan (REVERECE)
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000011294
- Lead Sponsor
- REVERCE study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 180
Not provided
1)Previous treatment with regorafenib, anti-EGFR antibody (cetuximab/panitumumab) or participation in clinical trial for regorafenib 2)Poorly controlled hypertension (SBP>150 mmHg or DBP >90 mmHg despite appropriate treatment) 3)Unstable angina, myocardial infarction, brain infarction, or pulmonary embolism within 6 months before entry 4)Body cavity fluid (e.g., pleural effusion, ascites, pericardial fluid) requiring intervention 5)Local or systemic active infection (grade 3 or higher according to the CTCAE ver. 4) requiring intervention 6)Symptomatic brain metastasis or brain metastasis requiring regular medication (e.g., mannitol, steroids, antiepileptic drugs) 7)Intestinal paralysis or severe gastrointestinal obstruction 8)Patients unable to swallow oral medications 9)Grade 3 or higher hemorrhage within 4 weeks before entry 10)History or clear evidence in CT scanof extensive interstitial pulmonary disease (e.g., interstitial pneumonia, pulmonary fibrosis) 11)Heart failure ≥ NYHA II 12)History of meningitis carcinomatosis, uncontrollable seizures (status epilepticus, intractable epilepsy), clinically significant mental disorder, or central nerve disorder 13)Active hepatitis B or C 14)Other active malignancies that may affect the prognosis 15)Pregnant or possibly pregnant women, lactating women, or patients unwilling to use adequate contraception 16)Uncontrolled diarrhea (diarrhea interfering with daily life despite appropriate treatment) 17)Unhealed wound (excluding central venous port), ulcer, or bone fracture 18)Any major surgery. open biopsy or traumatic injury within 28 days before enrollment (excluding the same day of the week 4 weeks ago) or colostomy without intestinal resection within 14 days before enrollment 19)Daily systemic steroid treatment (for such as collagen disease) 20)Known hypersensitivity to study drugs, study drug classes, or excipients in the formulation 21)Patients who, in the opinion of the investigator, are inappropriate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method