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)

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: JPRN-UMIN000015131
• Lead Sponsor: Kyushu Study group of Clinical Cancer

Brief Summary

13th JSMO Prophylactic Oral Steroids for Fatigue and Malaise due to Regorafenib : a Randomized Phase II trial (KSCC1402/HGCSG1402) S.Yuki, Y.Miyamoto, Y.Emi, M.Shimokawa, S.Tokunaga, M.Nakamura, Y.Komatsu, T.Yamaguchi,H. Baba, Y. Maehara; Kyushu Study group of Clinical Cancer(KSCC), Hokkaido Gastrointestinal Cancer Study Group (HGCSG) ASCO 2016 A randomized, double-blind, placebo-controlled phase II study of prophylactic dexamethasone therapy for fatigue and malaise due to regorafenib in patient with metastatic colorectal cancer: (KSCC1402/HGCSG1402) Miyamoto Y, Yuki S, Shimokawa M, Tanioka H, Tsuji A, Asayama M, Shiraishi T, Kotaka M, Makiyama A, Komatsu Y, Masuda S, Yamaguchi T, Saeki H, Oki E, Emi Y, Baba H, Maehara Y, Kyushu Study Group of Clinical Cancer (KSCC) ESMO-GI 2016 Updated report: A randomized, double-blind, placebo-controlled phase II study of prophylactic dexamethasone (dex) therapy for fatigue and malaise due to regorafenib in patient (pts) with metastatic colorectal cancer (mCRC):(KSCC1402/HGCSG1402) Yuki S, Komatsu Y, Satake H, Miyamoto Y, Tanioka H, Tsuji A, Asayama M, Shiraishi T, Kotaka M, Makiyama A,Kashiwada T, Takeuchi N, Shimokawa M, Saeki H, Oki E, Emi Y, Baba H, Maehara Y;Kyushu Study group of Clinical Cancer (KSCC), Hokkaido Gastrointestinal Cancer Study Group (HGCSG)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients who have used regorafenib previously. 2)Patients with Grade 2 or higher fatigue or malaise according to NCI-CTCAE (ver.4.0). 3)Patients with a history of a different type of cancer according to histological findings or cancer of a different primary focus within the past 5 years. However, 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. 4)Patients who have undergone highly invasive surgery, an open biopsy, or who have received significant trauma within 28 days of initiating regorafenib treatment. 5)Patients with congestive cardiac failure of NYHA Class 2 or higher. 6)Patients with 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. 7)Patients with arrhythmia requiring treatment with anti-arrhythmia drugs. 8)Patients with uncontrollable hypertension (systolic >150 mmHg or diastolic >90 mmHg even with hypotensives) 9)Patients with pleural effusion or ascites causing dyspnea (NCI-CTCAE (ver. 4.0) Grade 2 or higher). 10)Patients with a history of venous or arterial thrombosis or embolism within 6 months prior to initiation of treatment, including cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism. 11)Patients with active infections of NCI-CTCAE (ver. 4.0) Grade 3 or higher. 12)Patients positive for either HBs antigen or HCV antibody (testing required) HBc antibody test required prior to initiation of treatment. 33)Patients with 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of fatigue or malaise (CTCAE ver. 4, all grades)

Secondary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory(Patient Reported Outcome),adverse events,relative dose intensity (regorafenib) Exploratory endpoint : Compliance (regorafenib, study drug), response rate, disease control rate (DCR), treatment continuation period, progression-free survival (PFS), overall survival (OS)