Clinical trial · Interventional
Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adverse event | Other | — | UNRESOLVED |
| Blood pressure | Other | — | UNRESOLVED |
| Brain MRI | Other | — | UNRESOLVED |
| Clinical findings | Other | — | UNRESOLVED |
| Coagulation and fibrinolysis system | Other | — | UNRESOLVED |
| Contrast-enhanced torso CT | Other | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| General condition | Other | — | UNRESOLVED |
| Hematology/blood chemistry | Other |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment group
- description
- 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
- interventionNames
- Other: General condition
- Other: Blood pressure
- Other: Patient Reported Outcome
- Other: Clinical findings
- Other: Hematology/blood chemistry
- Other: Coagulation and fibrinolysis system
- Other: Urinalysis
- Other: Medication check
- Other: Adverse event
- Other: Thyroid function test
- Other: Contrast-enhanced torso CT
- Other: Brain MRI
- Drug: Dexamethasone
- Drug: Regorafenib
- Drug: Proton pump inhibitor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
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