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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003783
Receipt No. R000004238
Scientific Title A multicenter randomized phase II/III trial of preoperative versus postoperative chemotherapy with XELOX plus bevacizumab in patients with resectable colorectal liver metastasis.
Date of disclosure of the study information 2010/07/01
Last modified on 2019/04/21

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Basic information
Public title A multicenter randomized phase II/III trial of preoperative versus postoperative chemotherapy with XELOX plus bevacizumab in patients with resectable colorectal liver metastasis.
Acronym Randomized phase II/III trial of preoperative versus postoperative chemotherapy in patients with resectable colorectal liver metastasis. (HiSCO-01)
Scientific Title A multicenter randomized phase II/III trial of preoperative versus postoperative chemotherapy with XELOX plus bevacizumab in patients with resectable colorectal liver metastasis.
Scientific Title:Acronym Randomized phase II/III trial of preoperative versus postoperative chemotherapy in patients with resectable colorectal liver metastasis. (HiSCO-01)
Region
Japan

Condition
Condition Resectable liver metastasis from colorectal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Compare the progression-free survival of patients with resectable colorectal liver metastases treated with surgery and preoperative or postoperative XELOX and bevacizumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Treatment compliance (phase II)
Progression-free survival (phase III)
Key secondary outcomes Overall survival, Time to treatment failure, Response rate, Mode of recurrence, Resection rate, Incidence of adverse events, Morbidity, Pathological liver injury

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
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 Maneuver
Interventions/Control_1 A: Within 56 days after surgery, patients receive infusional oxaliplatin and oral capecitabine. Patients receive infusional bevacizumab as from second course. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Interventions/Control_2 B: Patients receive infusional oxaliplatin, bevacizumab and oral capecitabine. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients do not receive bevacizumab at last course. Within 56 days after chemotherapy, patients receive surgery.
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 adenocarcinoma
2) Four or less liver metastasis or maximum size of 5cm or less
3) Liver metastasis curable within 60% liver resection
4) No extrahepatic disease
5) Primary colorectal lesion curable or after curative resection
6) No prior radiofrequency ablation or cryotherapy for liver metastasis
7) No prior chemotherapy or radiotherapy
8) Child-Pugh class A
9) No evident bleeding or obstruction due to colorectal cancer
10) Patient age is 20 or more and 80 or less.
11) PS: 0, 1
12) Organ function is kept
13) Written informed consent
Key exclusion criteria 1) Multiple cancer patients
2) Pregnant or lactating woman
3) Steroid administration
4) Patients must use flucytosine, phenytoin or warfarin potassium
5) Uncontrollable hypertension or diabetes mellitus
6) Diarrhea or peripheral neuropathy greater than grade 1
7) Portal vein embolization
8) Clinically significant pulmonary disease, coagulopathy or thrombosis.
9) Clinically significant gastrointestinal bleeding, obstruction or ulcer.
10) Clinically significant abdominal, pleural or pericardial effusion.
11) Presence of psychological or central nervous system disorder.
12) Major abdominal or thoracic surgery within 4 weeks.
13) Presence of non-healing bone fracture
14) Hepatitis B virus infection
Target sample size 260

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Ohdan
Organization Hiroshima University Hospital
Division name Gasroenterological Surgery
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL 082-257-5222
Email jimukyoku@hisco-jpn.com

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

Sponsor
Institute Hiroshima Surgical study group of Clinical Oncology
Institute
Department

Funding Source
Organization Hiroshima Surgical study group of Clinical Oncology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization the institutional review board of Hiroshima University
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
Tel 082-257-5907
Email gaku-hiroshimajimu@office.hiroshima-u.ac.jp

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 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)、吉田総合病院(広島県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 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 81
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason in preparation
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 No longer recruiting
Date of protocol fixation
2010 Year 05 Month 20 Day
Date of IRB
2010 Year 05 Month 28 Day
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 19 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004238

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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