A Study of Prophylactic Oral Steroids for Fatigue and Malaise Due to Regorafenib Treatment for Unresectable Metastatic Colorectal Cancer: a Randomized, Placebo-controlled, Double-blind Phase 2 Clinical Study (KSCC1402/HGCSG1402)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- incidence of fatigue or malaise (CTCAE ver. 4, all grades)
研究概览
简要总结
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 treatment, as well as to assess treatment continuation of regorafenib.
详细描述
- 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 Research Support Center (CReS) Kyushu registration/allocation system. The registration with the registration/allocation system is available for 24 hr (URL: https://reg.cres-kyushu.or.jp/qmin/login/) and needs for individual identifier (ID) and password. 2. Quality management
- Preparation and management of the test drugs
The test drugs are an active drug, which is a capsule filled with dexamethasone powder and lactose, and a placebo, which is a capsule filled with only lactose. The test drugs will be prepared by the Department of Pharmacy (manager: Professor Masuda), Kyushu University Hospital in accordance with the procedures for preparation of the test drugs. Dexamethasone powder and lactose will be purchased by Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University from Tomita Pharmaceutical and delivered to the pharmacy department. Research funds will be used for the purchase. The capsule will be purchased from Tomita Pharmaceutical. The test drugs will be delivered to CReS-Kyushu (enrollment/data center) and managed using a double-blind method in accordance with the procedures. The double-blind code will be kept by the person responsible for management of the test drugs Shoji Tokunaga, Medical Information Center, Kyushu University, and a backup of the code will be kept by Hidekazu Aratani of CReS-Kyushu.
The test drugs will be managed according to the investigational drug number and stored at the warehouse of the Fukuoka branch of Yamato Logistics Co., Ltd. The warehouse is certified to store drugs for humans for more than 2 years under the supervision of pharmacists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: General condition (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Blood pressure (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Patient Reported Outcome (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Clinical findings (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Hematology/blood chemistry (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Coagulation and fibrinolysis system (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Urinalysis (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Medication check (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Adverse event (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Thyroid function test (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Contrast-enhanced torso CT (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Brain MRI (Other)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Dexamethasone (Drug)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Regorafenib (Drug)
Treatment group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), test drug capsule (dexamethasone 2 mg) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medicatiob check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Proton pump inhibitor (Drug)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: General condition (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Blood pressure (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Patient Reported Outcome (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Clinical findings (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Hematology/blood chemistry (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Coagulation and fibrinolysis system (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Urinalysis (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Medication check (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Adverse event (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Thyroid function test (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Contrast-enhanced torso CT (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Brain MRI (Other)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Regorafenib (Drug)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Placebo (Drug)
Placebo group
Treatment with regorafenib (160 mg/day, oral administration, 3 weeks on therapy followed by 1 week off therapy), placebo capsule (lactose) and proton pump inhibitors (PPIs) will be started within 14 days of enrollment. The protocol treatment period is 4 weeks.
Follow-up treatment for the underlying disease after the 4-week protocol treatment is not specified. The physician in charge will decide whether or not to continue treatment with regorafenib. For the prevention of fatigue/malaise, dexamethasone 2 mg can be used.
General condition, blood pressure, Patient Reported Outcome, clinical findings, hematology/blood chemistry, coagulation and fibrinolysis system, urinalysis, medication check, adverse event, thyroid function test, brain MRI, Contrast-enhanced torso CT
干预措施: Proton pump inhibitor (Drug)
结局指标
主要结局
incidence of fatigue or malaise (CTCAE ver. 4, all grades)
时间窗: 4weeks
With the number of subjects in safety analysis set (SAS) as the denominator, the frequency of the worst grade of "fatigue" or "malaise"(according to CTCAE ver.4.0) is determined.
次要结局
- brief fatigue inventory （Patient Reported Outcome）(4weeks)
- adverse events(1year)
- relative dose intensity (regorafenib)(4weeks)
研究者
Hideo Baba
Professor
Kumamoto University