UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003783 |
|---|---|
| Receipt number | 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 12:53:55 |
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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
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
tsukoba@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Surgical study group of Clinical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004238
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