Status:
UNKNOWN
Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)
Lead Sponsor:
Clinical Research Support Center Kyush
Conditions:
Rectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from regorafenib ...
Detailed Description
1. Patient registration procedure If it is confirmed that the subject meets the inclusion criteria and correspondent none of the exclusion criteria, the subject is registered by using Clinical Res...
Eligibility Criteria
Inclusion
- Capable of granting informed consent in writing for receiving treatment outlined in this protocol
- The investigators determines that the patient can receive the treatment outlined in this protocol
- Histological diagnosis of adenocarcinoma of either the colon or the rectum, regardless of RAS mutation
- Metastatic colorectal cancer scheduled for treatment with regorafenib
- Lesions are either measurable or non-measurable according to RECIST ver. 1.1
- Contrasted torso CT within 28 days before enrollment
- At least 20 years of age
- PS 0-1
- Bone marrow, hepatic, and renal functions have all been confirmed as normal within 14 days prior to initiation of regorafenib treatment
- Life expectancy of at least 3 months
Exclusion
- Used regorafenib previously
- Blood transfusion or granulocyte-colony stimulating factor (G-CSF) administration within 14 days
- Grade 2 or higher fatigue or malaise or asthenia according to NCI-CTCAE ver. 4.0
- History of a different type of cancer according to histological findings or cancer of a different primary focus within the past 5 years. 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
- Highly invasive surgery, an open biopsy, or who have received significant trauma within 28 days of initiating regorafenib treatment
- Congestive cardiac failure of New York Heart Association (NYHA) \>=Class 2
- 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
- Arrhythmia requiring treatment with anti-arrhythmia drugs
- Uncontrollable hypertension
- Pleural effusion or ascites causing dyspnea (NCI-CTCAE \>=Grade 2)
- History of venous or arterial thrombosis or embolism within 6 months prior to initiation of treatment, including cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism
- Patients with active infections of NCI-CTCAE \>=Grade 3
- Positive for either hepatitis B (HB)s antigen or hepatitis C virus (HCV) antibody
- Seizure disorders requiring drug treatment
- Cerebral metastases or history of such
- History of organ transplant
- Symptoms or history of hemorrhagic tendency, regardless of severity
- Some form of hemorrhaging (NCI-CTCAE \>=Grade 2) within 4 weeks prior to initiating treatment
- Incurable wound, fracture or ulcer
- Renal failure requiring either hemodialysis or peritoneal dialysis
- Dehydration symptoms of NCI-CTCAE \>=Grade 1
- Abusing drugs or who are in a physical, psychological, or social state which might impair study participation or evaluation of results
- Interstitial lung disease with active signs or symptoms
- Have difficulty taking oral drugs
- Digestion absorption disorders
- Adverse events resulting from previous treatments or procedures which have not yet resolved (NCI-CTCAE \>=Grade 2)
- Received systemic anti-cancer treatments within 2 weeks prior to initiation of regorafenib treatment, including chemotherapy, molecular target drugs, immunotherapy, or hormone therapy
- Poorly controlled glucose tolerance abnormalities due to diabetes mellitus (patients using insulin)
- Active GI ulcers or a history of such
- Glaucoma
- Oral steroids are otherwise contraindicated
- Either pregnant or nursing. Women who may become pregnant must have a negative pregnancy test within 7 days prior to initiating treatment
- Women who may become pregnant, or men whose partners may become pregnant, must agree to use appropriate contraceptives from granting of consent to 3 months after conclusion of regorafenib therapy
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02288078
Start Date
October 1 2014
End Date
September 1 2016
Last Update
November 13 2014
Active Locations (1)
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1
Saiseikai Fukuoka General Hospital
Fukuoka, Japan, 810-0001