UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006307 |
|---|---|
| Receipt number | R000007472 |
| Scientific Title | Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy. |
| Date of disclosure of the study information | 2011/09/08 |
| Last modified on | 2017/01/13 13:50:37 |
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Basic information
Public title
Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.
Acronym
Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.(KSCC1102)
Scientific Title
Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.
Scientific Title:Acronym
Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.(KSCC1102)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of S-1 plus irinotecan combined with bevacizumab in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Response rate
Overall Survival
Time to Treatment Failure
Safety
Investigation of Nausea and vomiting
Quality of life
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 |
Interventions/Control_1
CPT-11 150mg/m2 i.v. (day1)
Bev 7.5mg/kg i.v. (day1)
S-1 80mg/m2 p.o. (day1-14)
to be repeated every 3 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent
2) Appropriate for the study at the physician's assessment
3) Histopathology confirmed colorectal cancer.
4) Previously received oxaliplatin-based chemotherapy as 1st-line chemotherapy.
5) No prior radio-therapy for target lesion.
6) Aged 20<= years
7) ECOG performance status of 0-1.
8) At least one measurable lesion based on the RECIST criterion. (within 28 days before registration).
9) Be able to take oral drugs
10) Required baseline laboratory parameters (within 14 days before registration):
WBC: >= 3000 ,<=12000/mm3
Neu: >= 1,500/ mm3
Plt: >= 100,000/ mm3
Hb: >= 9.0g/dL
T-Bil: <= 2.0mg/dL
AST,ALT: <= 100IU/L
(<= 200IU/L if with Liver metastasis)
Cre: <1.5mg/dL
Ccr: >= 50mL/min
Urinary protein: <= grade1 (+1 or 0.15-1.0g/24h)
UGT1A1 genotype: wild type and *6,*28 heterozygote
11) Life expectancy at least 3 months.
Key exclusion criteria
1) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, poorly-controlled diabetes, poorly-controlled hypertension)
2) Symptomatic or asymptomatic but treated heart disease
3) Active infection..
4) Pleural effusion, peritoneal fluid
5) History of serious drug hypersensitivity or a history of drug allergy
6) Active other malignancies.
7) History of mental disturbances or cerebrovascular attack, central nervous system disorder
8) Brain metastasis
9) Peptic ulcer, bleeding, intestinal obstruction, intestinal paralysis , gastrointestinal perforation
10) History of gastrointestinal perforation
11) Watery stools or grade 2 or more diarrhea
12) History of thromboembolism, cerebral infarction
13) Hemorrhagic diathesis, coagulation disorder
14) Requiring anti-thrombogenic therapy to prevent thrombosis
15) Requiring steroid drug
16) Receiving flucytosine, atazanavir sulfate
17) Pregnant or lactating woman
18) No birth-control
19) Treatment history of irinotecan
20) History of hemoptysis
21) Contraindication to S-1, CPT-11, bevacizumab
22) High-grade stricture
23) Not appropriate for the study at the physician's assessment
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ogata |
Organization
Kurume university medical center
Division name
Surgery
Zip code
Address
155-1 kokubun-cho, Kurume city, 839-0863, Japan
TEL
0942-22-6111
kscc2@cres-kyushu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KSCC |
Organization
Clinical Research Support Center Kyushu
Division name
KSCC
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL
092-631-2920
Homepage URL
kscc2@cres-kyushu.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
鹿児島県立薩南病院(鹿児島県)、宗像医師会病院（福岡県）、佐世保市立総合病院（長崎県）、健康保険人吉総合病院（熊本県）、国立病院機構別府医療センター（大分県）、済生会福岡総合病院（福岡県）、大牟田市立病院（福岡県）、社会保険田川病院（福岡県）、社会保険久留米第一病院（福岡県）、熊本大学（熊本県）、松山赤十字病院（愛媛県）、国立病院機構南九州病院（鹿児島県）、福岡市民病院（福岡県）、国立病院機構大分医療センター（大分県）、中津市立中津市民病院（大分県）、長崎大学（長崎県）、鹿児島共済会南風病院（鹿児島県）、済生会八幡総合病院（福岡県）、熊本中央病院（熊本県）、高地医療センター（高知県）、春回会 井上病院（長崎県）、大分赤十字病院（大分県）、製鉄記念八幡病院（福岡県）、公立学校共済組合九州中央病院（福岡県）、神戸市立医療センター中央市民病院（兵庫県）、久留米大学医療センター（福岡県）、今給黎総合病院（鹿児島県）、済生会川内病院（鹿児島県）、長崎百合野病院（長崎県）、鹿児島大学（鹿児島県）、宮崎県立日南病院（宮崎県）、健康保険八代総合病院（熊本県）、中頭病院（沖縄県）、久留米大学（福岡県）、九州大学（福岡県）、聖マリア病院（福岡県）、岡山労災病院（岡山県）、豊見城中央病院（沖縄県）、済生会熊本病院(熊本県）、大分県立病院（大分県）、国立病院機構福岡東医療センター（福岡県）、田川市立病院（福岡県）、社会保険仲原病院（福岡県）、県民健康プラザ鹿屋医療センター（鹿児島県）、高野会 高野病院（熊本県）、独立行政法人国立病院機構熊本再春荘病院（熊本県）、熊本市立熊本市民病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26746689
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
| 2011 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 04 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2017 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007472
