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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004976
Receipt No. R000005915
Scientific Title A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02)
Date of disclosure of the study information 2011/03/01
Last modified on 2018/06/14

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Basic information
Public title A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02)
Acronym A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02)
Scientific Title A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02)
Scientific Title:Acronym A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02)
Region
Japan

Condition
Condition Unresectable advanced/metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness and safety of S-1/oxaliplatin (SOX)+bevacizumab combination therapy in patients with unresectable advanced/metastatic colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival, Overall survival, Incidence and degree of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 Patients receive infusional oxaliplatin, bevacizumab, and oral TS-1 every 21 days.
Interventions/Control_2
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed colorectal cancer (adenocarcinoma).
2) Clinically proven unresectable advanced/
metastatic colorectal cancer
3) 20 to 79 years of age
4) ECOG performance status 0-1
5) Presence of measurable lesion
6) No previous history of chemotherapy or radiotherapy for unresectable advanced/
metastatic colorectal cancer
7) Oral food intake possible
8) Adequate organ functions
9) Estimated life expectancy more than 3 months
10) Written informed consent
Key exclusion criteria 1) History of serious drug hypersensitivity
2) Pregnant or possibly pregnant females, or
males with female partners who are planning to pregnancy
3) Severe infectious disease
4) Severe comorbidity (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, uncontrollable hypertension, uncontrollable diabetes mellitus, etc)
5) Comorbidity or history of heart failure
6) Evidence of gastrointestinal ulcer or bleeding
7) Peripheral neuropathy
8) Wattery diarrhea
9) Massive pleural effusion or ascites
10) Clinical or radiological evidence of CNS metastases.
11) Current or previous (within the last 6 months) history of GI perforation
12) Previous history of thrombosis or cerebral infarction
13) Any surgical treatments within 28 days
14) Evidence of bleeding diathesis or coagulopathy
15) ongoing treatment with anticoagulant or aspirin (> 325mg/day)
16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
17) Previous history of adjuvant chemotherapy with oxaliplatin
18) Under coutinuous steroid administration
19) Any other serious or uncontrolled condition which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
20) Previous history of hemoptysis
21) Contraindication for administration of L-OHP, BV, TS-1, 5-FU, or l-LV
22) Presence of severe colorectal stricture
23) Radiological evidence of peritoneal dissemination
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinozaki Katsunori
Organization Hiroshima Prefectural Hospital
Division name Clinical Oncology
Zip code
Address 1-5-54 Ujina-Kanda, Minami-ku, Hiroshima, 734-8530, JAPAN
TEL 082-254-1818
Email k-shinozaki@hph.pref.hiroshima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kobayashi Tsuyoshi
Organization Hiroshima University Hospital
Division name Gasroenterological Surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL 082-257-5222
Homepage URL
Email tsukoba@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Study group of Clinical Oncology (HiSCO)
Institute
Department

Funding Source
Organization Hiroshima Study group of Clinical Oncology (HiSCO)
Organization
Division
Category of Funding Organization Self funding
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 安佐市民病院(広島県)、井野口病院(広島県)、太田川病院(広島県)、尾道総合病院(広島県)、呉医療センター(広島県)、呉市医師会病院(広島県)、県立広島病院(広島県)、庄原赤十字病院(広島県)、中国労災病院(広島県)、中電病院(広島県)、土谷総合病院(広島県)、東広島医療センター(広島県)、広島市民病院(広島県)、広島大学病院(広島県)、広島鉄道病院(広島県)、広島西医療センター(広島県)、三次中央病院(広島県)、柳井医療センター(山口県)、吉田総合病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 01 Day

Related information
URL releasing protocol http://hisco-jpn.com/pdf/HiSCO-02outline.pdf
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27803845
Number of participants that the trial has enrolled
Results
PURPOSE:FOLFOX is a standard combination chemotherapy regimen for metastatic colorectal cancer (CRC). 5-Fluorouracil (5-FU) is infused continuously through a pump for 46 h; therefore, replacement of infused 5-FU with oral S-1 would be more convenient for patients. We investigated the efficacy and safety of S-1/oxaliplatin (SOX) plus bevacizumab regimen in a community setting.
METHODS:We conducted a phase II clinical study in Hiroshima, Japan. We enrolled individuals aged 20-80 years who had metastatic CRC, an Eastern Cooperative Oncology Group performance status of 0 or 1, assessable lesions, and not received previous chemotherapy. Eligible patients were administered SOX plus bevacizumab (S-1 80 mg/m2/day, day 1-14 orally; and oxaliplatin 130 mg/m2 day 1 i.v., bevacizumab 7.5 mg/kg, day 1 i.v. q3w). The primary endpoint was response rate (RR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.
RESULTS:Between May 2011 and January 2014, 55 patients (mean age 64 years) were enrolled at 12 institutions. Median follow up duration was 20.2 months (range 1.3-47.1 months). RR was 47.1 % [95 % confidence interval (CI) 33.7-60.6 %]. Median PFS and OS was 9.2 months (95 % CI 7.6-10.8) and 22.5 months (95 % CI 19.4-25.9), respectively. Major adverse events (grade 3/4) were neutropenia (9.3 %), thrombocytopenia (5.6 %), anorexia (18.5 %), and sensory neuropathy (16.7 %).
CONCLUSION:These data suggested that SOX plus bevacizumab is effective and capable of being managed in metastatic CRC patients in our community clinical practice.
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
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 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
2011 Year 01 Month 28 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005915

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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