UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012276 |
|---|---|
| Receipt number | R000014352 |
| Scientific Title | Randomized phase II trial of Hange-shasin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer under IRIS+Bev second-line treatment |
| Date of disclosure of the study information | 2013/11/13 |
| Last modified on | 2017/05/18 20:25:46 |
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Basic information
Public title
Randomized phase II trial of Hange-shasin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer under IRIS+Bev second-line treatment
Acronym
Randomized phase II trial of Hange-shasin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer under IRIS+Bev second-line treatment
Scientific Title
Randomized phase II trial of Hange-shasin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer under IRIS+Bev second-line treatment
Scientific Title:Acronym
Randomized phase II trial of Hange-shasin-to versus placebo to prevent diarrhea in patients with metastatic colorectal cancer under IRIS+Bev second-line treatment
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of prophylactic administration of Hange-shashin-to with Irinotecan + S-1 + Bevacizumab, induce diarrhea, for second-line chemotherapy in patients with metastatic colorectal cancer, and also to evaluate efficacy and safety of IRIS/Bev treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of grade 3 or more diarrhea until the end of 3rd cycle
Key secondary outcomes
Response rate
Progression Free Survival
Time to Treatment Failure
Overall Survival
Incidence and severity of adverse events
Dose intensity
Frequency of rescue medication for diarrhea
Compliance
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
S-1+CPT-11+bevacizumab+Placebo
S-1 80-120mg/day day1-14 q4w
CPT-11 100mg/m2 day1,15 q4w
Bevacizumab 5mg/kg day1, 15 q4w
Placebo day1-28 q4w
Interventions/Control_2
S-1+CPT-11+bevacizumab+hange-shashin-to
S-1 80-120mg/day day1-14 q4w
CPT-11 100mg/m2 day1,15 q4w
Bevacizumab 5mg/kg day1, 15 q4w
Hange-shashin-to 7.5g/day day1-28 q4w
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) Histologically confirmed colorectal cancer (adenocarcinoma) except for appendiceal cancer
2) Unresectable or recurrent colorectal cancer
3) Age of 20 years or older
4) ECOG Performance status of 0-2
5) Measurable or evaluable lesions
6) Received prior Oxaliplatin-containing first line chemotherapy
7) Sufficient oral intake
8) Sufficient major organ functions below:
Neutrophil count >= 1,500 /mm3
Platelet count >= 100,000 /mm3
Hemoglobin >= 9.0 g/dL
AST <= 100 IU/L
ALT <= 100 IU/L
Total bilirubin <= 1.5 mg/dL
Serum creatinine <= 1.2 mg/dL
Creatinine clearance >= 60 mL/min
Urine protein <= Grade 1
9) Life expectancy of at least 3 months
10) Written informed consent
Key exclusion criteria
1) History of severe drug allergies except for ones related by Oxaliplatin
2) Received radiation therapy to the abdomen
3) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less). Carcinoma in situ decided cure by treatment, differentiated gastric mucosal cancer or skin cancer will be permitted for registration
4) Active infections
5) Gastrointestinal perforation, Paresis of intestine, Ileus induced by bevacizumab
6) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure and so on.
7) Aldosteronism, myopathy
8) Severe hypokalemia
9) Ascites or pleural effusion requiring treatment
10) Watery diarrhea
11) Current use of flucytosine and/or atazanavir
12) Current use of drug for controlling intestinal function such as Lactomin or Bifidobacterium preparation
13) Symptomatic brain metastasis
14) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy
15) Severe mental disorder
16) Thrombosis, cerebral infarction, myocardial infarction, lung infarction within 6 months before enrollment
17) Surgery and/or biopsy with surgical incision within 4 weeks except for placement of central venous access port
18) Homozygous genotype of UGT1A1*28 or UGT1A1*6, and double heterozygous genotype of UGT1A1*28 and UGT1A1*6
19) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Komatsu |
Organization
Hokkaido University Hospital
Division name
Department of Cancer Chemotherapy
Zip code
Address
North 14, West 5,Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-5657
ykomatsu@ac.cyberhome.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshito Komatsu |
Organization
Hokkaido University Hospital
Division name
Department of Cancer Chemotherapy
Zip code
Address
North 14, West 5,Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-706-5657
Homepage URL
ykomatsu@ac.cyberhome.ne.jp
Sponsor or person
Institute
NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Institute
Department
Personal name
Funding Source
Organization
NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院、他、HGCSG参加施設ならびに研究協力施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 13 | 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
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
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 13 | 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
| 2013 | Year | 11 | Month | 12 | Day |
Last modified on
| 2017 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014352
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