Colorectal Cancer
Conditions
Interventions
Treatment group Regorafenib 160mg Once daily, 3weeks on, 1week off plus Study drug capsule (Dexamethasone 2mg), once daily
Placebo group Regorafenib 160mg Once daily, 3weeks on, 1week off plus
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is capable of granting informed consent in writing for receiving treatment outlined in this protocol. 2) The investigators determine that the patient can receive the treatment outlined in this protocol. 3) Patient has received histological diagnosis of adenocarcinoma of either the colon or the rectum (including anus), regardless of RAS mutation. 4) Patient has metastatic colorectal cancer that is scheduled for treatment with regorafenib. 5) Patient has lesions which are either measurable or non-measurable according to RECIST version 1.1. 6) Trunk part contrasting CT (the chest, epigastric region, pelvis) until 28 days before the registration. When contrasting CT is impossible for an allergy to contrast agents, the registration is possible only in trunk part simple CT. 7) Patient is at least 20 years of age. 8) PS(ECOG) 0-1 9) Patients for whom bone marrow, hepatic, and renal functions have all been confirmed as normal within 7 days prior to initiation of regorafenib treatment according to the following clinical test standards Total bilirubin >= 2.0 mg/dL AST <= 100 IU/L (;200 for patients with liver metastases) ALT <= 100 IU/L (;200 for patients with liver metastases) Creatinine <= 1.5mg/dL Creatinine clearance >= 60mL/min Persistent proteinuria of Grade 2 or lower according to NCI-CTCAE (ver. 4.0) (>3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample). INR <= 1.5 Plt >= 100,000/ mm3 Hb >= 9.0g/dl Neu >= 1,500/ mm3 10) Patients with life expectancy of at least 3 months
Exclusion criteria
Exclusion criteria: 1) Patients who have used regorafenib previously. 2) Patients with Grade 2 or higher fatigue or malaise according to NCI-CTCAE (ver.4.0). 3) Patients with a history of a different type of cancer according to histological findings or cancer of a different primary focus within the past 5 years. However, the following are excluded: carcinoma in situ of the cervix, non-melanoma skin cancer, superficial bladder cancer (Ta, Tis, and T1), gastric cancer, non-invasive breast cancer, etc. 4) Patients who have undergone highly invasive surgery, an open biopsy, or who have received significant trauma within 28 days of initiating regorafenib treatment. 5) Patients with congestive cardiac failure of NYHA Class 2 or higher. 6) Patients with unstable angina (symptoms at rest),new-onset angina (onset within past 3 months), or a history of myocardial infarction within 6 months of initiating treatment. 7) Patients with arrhythmia requiring treatment with anti-arrhythmia drugs. 8) Patients with uncontrollable hypertension (systolic >150 mmHg or diastolic >90 mmHg even with hypotensives) 9) Patients with pleural effusion or ascites causing dyspnea (NCI-CTCAE (ver. 4.0) Grade 2 or higher). 10) Patients with a history of venous or arterial thrombosis or embolism within 6 months prior to initiation of treatment, including cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism. 11) Patients with active infections of NCI-CTCAE (ver. 4.0) Grade 3 or higher. 12) Patients positive for either HBs antigen or HCV antibody (testing required) HBc antibody test required prior to initiation of treatment. 33) Patients with other illnesses or conditions which, according to the judgment of the investigator, may result in physical harm caused by the study, or which may impair study compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of fatigue or malaise (CTCAE ver. 4, all grades) | — |
Secondary
| Measure | Time frame |
|---|---|
| Brief Fatigue Inventory(Patient Reported Outcome),adverse events,relative dose intensity (regorafenib) Exploratory endpoint : Compliance (regorafenib, study drug), response rate, disease control rate (DCR), treatment continuation period, progression-free survival (PFS), overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactClinical Research Support Center Kyushu
KSCC Research Secretariat KSCC Research Secretariat
Outcome results
None listed