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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015131
Receipt No. R000017600
Scientific Title 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)
Date of disclosure of the study information 2014/09/11
Last modified on 2017/04/30

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Basic information
Public title 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)
Acronym 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)
Scientific Title 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)
Scientific Title:Acronym 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)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence of fatigue or malaise (CTCAE ver. 4, all grades)
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment group
Regorafenib 160mg
Once daily, 3weeks on, 1week off
plus
Study drug capsule
(Dexamethasone 2mg), once daily
Interventions/Control_2 Placebo group
Regorafenib 160mg
Once daily, 3weeks on, 1week off
plus
Placebo capsule
(Lactose), once daily
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient is capable of granting informed consent in writing for receiving treatment outlined in this protocol.
2) The investigators determine that the patient can receive the treatment outlined in this protocol.
3) Patient has received histological diagnosis of adenocarcinoma of either the colon or the rectum (including anus), regardless of RAS mutation.
4) Patient has metastatic colorectal cancer that is scheduled for treatment with regorafenib.
5) Patient has lesions which are either measurable or non-measurable according to RECIST version 1.1.
6) Trunk part contrasting CT (the chest, epigastric region, pelvis) until 28 days before the registration. When contrasting CT is impossible for an allergy to contrast agents, the registration is possible only in trunk part simple CT.
7) Patient is at least 20 years of age.
8) PS(ECOG) 0-1
9) Patients for whom bone marrow, hepatic, and renal functions have all been confirmed as normal within 7 days prior to initiation of regorafenib treatment according to the following clinical test standards
Total bilirubin >= 2.0 mg/dL
AST <= 100 IU/L (;200 for patients with liver metastases)
ALT <= 100 IU/L (;200 for patients with liver metastases)
Creatinine <= 1.5mg/dL
Creatinine clearance >= 60mL/min
Persistent proteinuria of Grade 2 or lower according to NCI-CTCAE (ver. 4.0) (>3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
INR <= 1.5
Plt >= 100,000/ mm3
Hb >= 9.0g/dl
Neu >= 1,500/ mm3
10) Patients with life expectancy of at least 3 months
Key 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.
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Baba
Organization Graduate School of Life Sciences, Kumamoto University
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan
TEL 096-373-5212
Email kscc2@cres-kyushu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical Research Support Center Kyushu
Organization KSCC Research Secretariat
Division name KSCC Research Secretariat
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL 092-631-2920
Homepage URL https://www.ks-cc.jp
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 熊本市民病院(熊本県)
慈泉会相澤病院(長野県)
光晴会病院(長崎県)
九州大学 消化器・総合外科,血液・腫瘍内科(福岡県)
九州大学病院別府病院(大分県)
済生会福岡総合病院(福岡県)
久留米大学(福岡県)
久留米大学医療センター(福岡県)
佐世保市立総合病院(長崎県)
長崎大学 移植・消化器外科(長崎県)
熊本大学(熊本県)
大分赤十字病院(大分県)
国立病院機構大分医療センター(大分県)
中津市立中津市民病院(大分県)
鹿児島厚生連病院(鹿児島県)
松山赤十字病院(愛媛県)
神戸市立医療センター中央市民病院(兵庫県)
岡山労災病院(岡山県)
JCHO九州病院(福岡県)
県立広島病院(広島県)
那覇市立病院(沖縄県)
獨協医科大学(栃木県)
薫風会佐野病院(兵庫県)
国立病院機構熊本医療センター(熊本県)
山口県立総合医療センター(山口県)
伊那中央病院(長野県)
立川綜合病院(新潟県)
苫小牧日翔病院(北海道)
札幌医科大学(北海道)
北海道がんセンター(北海道)
佐賀大学(佐賀県)
北海道大学(北海道)
国立病院機構九州医療センター(福岡県)
岐阜大学(岐阜県)
国立病院機構九州がんセンター(福岡県)
名古屋大学(愛知県)
釧路ろうさい病院(北海道)
埼玉県立がんセンター(埼玉県)
飯塚病院(福岡県)
中部徳洲会病院(沖縄県)
浜の町病院(福岡県)
香川大学(香川県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 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)
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2017 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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