Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

Eastern Cooperative Oncology Group (ECOG) performance status (PS), height and body weight

systolic blood pressure (SBP)/diastolic blood pressure (DBP)

Incidence of fatigue or malaise (All grade of CTCAE ver. 4), anorexia, Brief fatigue inventory (BFI), FACT-C.

"* 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"

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

international normalized ratio (INR)

Proteinuria (qualitative)

Medicine taking situation (regorafenib, dexamethasone and placebo) determined by subject's diary at every courses

CTCAE ver.4.0

Thyroid-stimulating hormone (TSH), T4, and T3

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.

If any symptom of brain metastasis is suspected

Capsule filled with dexamethasone and lactose

Film-coating tablet contains 40 mg of regorafenib

Capsule filled with lactose

PPIs (omeprazole, lansoprazole, etc, as not specified) for prevention of peptic ulcer