切除不能な転移性大腸癌におけるレゴラフェニブ誘発性疲労／倦怠感に対する経口ステロイド療法（KSCC1402/HGCSG1402）

基本情報

NCT ID: NCT02288078
ステータス: 不明
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 74
治験依頼者名: Clinical Research Support Center Kyush

概要

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.

対象疾患

Rectal Cancer

介入

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(OTHER)

Dexamethasone(DRUG)

Regorafenib(DRUG)

Placebo(DRUG)

Proton pump inhibitor(DRUG)

依頼者（Sponsor）

Clinical Research Support Center Kyush(OTHER)

実施施設 (1)

福岡県済生会福岡総合病院

Fukuoka, Japan(RECRUITING)