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試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000002932
受付番号 R000003567
科学的試験名 進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール(ビタミンB6)予防投与の有効性に関する臨床評価
一般公開日(本登録希望日) 2010/01/01
最終更新日 2019/06/30

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール(ビタミンB6)予防投与の有効性に関する臨床評価 Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
一般向け試験名略称/Acronym 進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール予防投与の有効性に関する臨床評価 Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
科学的試験名/Scientific Title 進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール(ビタミンB6)予防投与の有効性に関する臨床評価 Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
科学的試験名略称/Scientific Title:Acronym 進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール予防投与の有効性に関する臨床評価 Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 進行・再発乳癌 Locally advanced or metastatic breast cancer
疾患区分1/Classification by specialty
血液・腫瘍内科学/Hematology and clinical oncology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 進行・再発乳癌患者に対し、カペシタビン単独又はカペシタビン併用化学療法を行い、カペシタビン初回治療例における手足症候群(HFS)に対するピリドキサール(ビタミンB6)投与の予防効果を検討する。 This randomized phase II trial evaluates pridoxine for preventing of hand-foot syndrome (HFS) compared with no pyridoxine in breast cancer patients treated with capacitabine.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅱ相/Phase II

評価/Assessment
主要アウトカム評価項目/Primary outcomes Grade2以上のHFS発現までの期間 Time to the onset of HFS (Grade2 or 3)
副次アウトカム評価項目/Key secondary outcomes ・HFSの発現割合(全Grade、Grade別)
・HFS発現までの期間(全Grade、Grade別)
・併用療法別HFSの発現状況
・カペシタビンの投与状況(投与量、投与期間、総投与量と総投与期間)
・安全性
・QOL(Skindex29)
・指圧計による指圧の変動
Incidence of HFS (any Grade)
Time to the onset of HFS (any Grade)
Incidence of HFS by chemotherapy type
Treatment duration and dosage of Capecitabine administration
Safety
Quality of life by Skindex29
Finger pressure by pinch meter

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification はい/YES
動的割付/Dynamic allocation はい/YES
試験実施施設の考慮/Institution consideration 動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 中央登録/Central registration

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1 ピリドキサール(ビタミンB6)非予防投与群:カペシタビン単独療法、カペシタビン+パクリタキセル併用療法、カペシタビン+シクロホスファミド併用療法のいずれかを行う No prodpxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy
介入2/Interventions/Control_2 ピリドキサール(ビタミンB6)予防投与群:カペシタビン単独又は併用療法にピリドキサール60mg/日の予防投与を行う Pridoxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy with pyridoxal 60mg po daily
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 女/Female
選択基準/Key inclusion criteria 1、組織学的診断で乳癌であることが確認されている進行・再発の乳癌患者
2、満20歳以上の女性患者
3、The Eastern Cooperative Oncology Group(ECOG) Performance Statusが0-1
4、経口摂取可能である患者
5、登録日から3カ月以上の生存が可能と期待される患者
6、患者本人から文書により試験参加に同意が得られていること
7、登録前21日以内の主要臓器機能について以下の規準を満たしている
1. Diagnosis of advanced breast cancer
2. 20 years old or more
3. ECOG performance status 0-1
4. Can eat
5. Life expectancy more than 3 months
6. Written informed consents
7. Sufficient organ functions
除外基準/Key exclusion criteria 1、フルオロウラシル製剤に対して重篤な過敏症の既往がある。またはDPD欠損が疑われるようなフルオロピリミジン系薬剤に対する副作用が発現したことのある患者
2、カペシタビンの治療歴を有する患者
3、本治療に支障をきたすおそれのある薬剤過敏症既往のある患者
4、コントロールできない重篤な合併症のある患者
5、登録までの無病期間5年未満の重複がんまたは合併を有する患者
6、妊娠または妊娠している可能性のある患者
7、その他、担当医師が不適と判断したもの
1. History of serious drug hypersensitivity or a history of drug allergy by fluoropyrimidine. History of adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase deficiency
2. Capecitabine used prior chemotherapy
3. History of drug hypersensitivity not suitable for this study
4. Uncontrolled serious complications
5. Multiple primary cancer within 5 years
6. Pregnant women or possibly pregnant women
7. Other conditions not suitable for this study
目標参加者数/Target sample size 150

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
竜也
ミドルネーム
遠山
Tatsuya
ミドルネーム
Toyama
所属組織/Organization 名古屋市立大学大学院 医学研究科 Nagoya City University Hospital
所属部署/Division name 乳腺外科学分野 Breast Surgery
郵便番号/Zip code 467-8601
住所/Address 名古屋市瑞穂区瑞穂町字川澄1番地 1, Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
電話/TEL 052-851-5511
Email/Email toyamat-ncu@umin.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
慶子
ミドルネーム
大森 
Keiko
ミドルネーム
Ohmori
組織名/Organization 東海乳癌臨床試験グループ(TBCRG) Tokai Breast Cancer Clinical Research Group (TBCRG)
部署名/Division name 事務局 Office
郵便番号/Zip code 464-8681
住所/Address 名古屋市千種区鹿子殿1-1 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
電話/TEL 052-762-6111
試験のホームページURL/Homepage URL
Email/Email hiwata@aichi-cc.jp

実施責任組織/Sponsor
機関名/Institute その他 Tokai Breast Cancer Clinical Research Group (TBCRG)
機関名/Institute
(機関選択不可の場合)
東海乳癌臨床試験グループ(TBCRG)
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Comprehensive Support Project for Oncological Research (CSPOR)
機関名/Organization
(機関選択不可の場合)
財団法人パブリックリサーチセンター乳癌臨床研究支援事業(CSPOR)
組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization 日本 Japan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 名古屋市立大学病院 Nagoya City University Hospital
住所/Address 名古屋市瑞穂区瑞穂町字川澄1番地 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
電話/Tel 0528515511
Email/Email toyamat-ncu@umin.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2010 01 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/29948956
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29948956
組み入れ参加者数/Number of participants that the trial has enrolled 135
主な結果/Results A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively. A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively.
主な結果入力日/Results date posted
2019 06 30
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.
参加者の流れ/Participant flow From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.
有害事象/Adverse events Leukopenia has not previously been reported
as an adverse event related to pyridoxine therapy. In this study, the median number of treatment cycles of capecitabine-containing chemotherapy was 5.5 and 4.0 in the pyridoxine and no pyridoxine groups, respectively. Therefore, the increased incidence of leukopenia in the pyridoxine group may be attributable to a longer exposure to chemotherapy.
Leukopenia has not previously been reported
as an adverse event related to pyridoxine therapy. In this study, the median number of treatment cycles of capecitabine-containing chemotherapy was 5.5 and 4.0 in the pyridoxine and no pyridoxine groups, respectively. Therefore, the increased incidence of leukopenia in the pyridoxine group may be attributable to a longer exposure to chemotherapy.
評価項目/Outcome measures A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no
pyridoxine groups, respectively.
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no
pyridoxine groups, respectively.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2009 11 09
倫理委員会による承認日/Date of IRB
2009 10 01
登録・組入れ開始(予定)日/Anticipated trial start date
2010 01 01
フォロー終了(予定)日/Last follow-up date
2012 06 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2009 12 22
最終更新日/Last modified on
2019 06 30


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000003567
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003567

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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