Study: NCT02288078

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: General condition
Description: Eastern Cooperative Oncology Group (ECOG) performance status (PS), height and body weight

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: General condition
Description: Eastern Cooperative Oncology Group (ECOG) performance status (PS), height and body weight

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Blood pressure
Description: systolic blood pressure (SBP)/diastolic blood pressure (DBP)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood pressure
Description: systolic blood pressure (SBP)/diastolic blood pressure (DBP)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Patient Reported Outcome
Description: Incidence of fatigue or malaise (All grade of CTCAE ver. 4), anorexia, Brief fatigue inventory (BFI), FACT-C.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Patient Reported Outcome
Description: Incidence of fatigue or malaise (All grade of CTCAE ver. 4), anorexia, Brief fatigue inventory (BFI), FACT-C.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Clinical findings
Description: * Blood and lymphatic system disorders: febrile neutropenia~* Gastrointestinal disorders: constipation, diarrhea, oral mucositis, nausea, and vomiting~* General disorders and administration site conditions: fatigue and malaise~* Immune system disorders: allergic reaction~* Metabolism and nutrition disorders: anorexia~* Nervous system disorders: dysgeusia and peripheral sensory neuropathy~* Respiratory, thoracic and mediastinal disorders: hoarseness (change of voice)~* Skin and subcutaneous tissue disorders: alopecia, skin hyperpigmentation, urticaria, and palmar-plantar erythrodysesthesia syndrome~* Vascular disorders: hypertension~* Symptomatic pancreatitis

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Clinical findings
Description: * Blood and lymphatic system disorders: febrile neutropenia~* Gastrointestinal disorders: constipation, diarrhea, oral mucositis, nausea, and vomiting~* General disorders and administration site conditions: fatigue and malaise~* Immune system disorders: allergic reaction~* Metabolism and nutrition disorders: anorexia~* Nervous system disorders: dysgeusia and peripheral sensory neuropathy~* Respiratory, thoracic and mediastinal disorders: hoarseness (change of voice)~* Skin and subcutaneous tissue disorders: alopecia, skin hyperpigmentation, urticaria, and palmar-plantar erythrodysesthesia syndrome~* Vascular disorders: hypertension~* Symptomatic pancreatitis

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Hematology/blood chemistry
Description: White blood cell count, absolute neutrophil count (stab + segmented), hemoglobin, platelet count, albumin, total bilirubin, aspartate aminotransferase(AST) (GOT), alanine aminotransferase (ALT) (GPT), serum creatinine, Na, K

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Hematology/blood chemistry
Description: White blood cell count, absolute neutrophil count (stab + segmented), hemoglobin, platelet count, albumin, total bilirubin, aspartate aminotransferase(AST) (GOT), alanine aminotransferase (ALT) (GPT), serum creatinine, Na, K

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Coagulation and fibrinolysis system
Description: international normalized ratio (INR)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Coagulation and fibrinolysis system
Description: international normalized ratio (INR)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Urinalysis
Description: Proteinuria (qualitative)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Urinalysis
Description: Proteinuria (qualitative)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Medication check
Description: Medicine taking situation (regorafenib, dexamethasone and placebo) determined by subject's diary at every courses

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medication check
Description: Medicine taking situation (regorafenib, dexamethasone and placebo) determined by subject's diary at every courses

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Adverse event
Description: CTCAE ver.4.0

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Adverse event
Description: CTCAE ver.4.0

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Thyroid function test
Description: Thyroid-stimulating hormone (TSH), T4, and T3

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Thyroid function test
Description: Thyroid-stimulating hormone (TSH), T4, and T3

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Contrast-enhanced torso CT
Description: It is recommended that CT images should be taken every 4 weeks (if possible) or at least every 8 weeks (allowable time window: ± 2 weeks), with the treatment phase taken into consideration.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Contrast-enhanced torso CT
Description: It is recommended that CT images should be taken every 4 weeks (if possible) or at least every 8 weeks (allowable time window: ± 2 weeks), with the treatment phase taken into consideration.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Brain MRI
Description: If any symptom of brain metastasis is suspected

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Brain MRI
Description: If any symptom of brain metastasis is suspected

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: Capsule filled with dexamethasone and lactose

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Regorafenib
Description: Film-coating tablet contains 40 mg of regorafenib

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Regorafenib
Description: Film-coating tablet contains 40 mg of regorafenib

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Capsule filled with lactose

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Proton pump inhibitor
Description: PPIs (omeprazole, lansoprazole, etc, as not specified) for prevention of peptic ulcer

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Proton pump inhibitor
Description: PPIs (omeprazole, lansoprazole, etc, as not specified) for prevention of peptic ulcer