UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031532 |
|---|---|
| Receipt number | R000035650 |
| Scientific Title | Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III) |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/08/14 10:04:35 |
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Basic information
Public title
Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Acronym
Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Scientific Title
Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Scientific Title:Acronym
Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Region
| Japan |
Condition
Condition
Stage III colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the superiority of disease-free survival of aspirin to placebo as adjuvant therapy for stage III colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
Overall survival, Relapse-free survival, Relative dose intensity, Adverse events, Sever adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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
A:Placebo. Patients in this group receive placebo for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine).
Interventions/Control_2
B:Aspirin. Patients in this group receive aspirin, at a dose of 100 mg for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine).
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) Pathologically proven colorectal adenocarcinoma.
2) Tumor is mainly located between cecum and upper rectum, excluding appendix and that invades to lower rectum.
3) Tumor resection with D2 or D3 lymph node dissection was performed.
4) R0 resection was performed.
5) Stage III cancer (UICC TNM classification 7th ed.).
6) No synchronous colorectal cancer which invade muscularis propria or deeper.
7) Age at registration is of 20 to 80 years old.
8) ECOG Performance status is 0 or 1.
9) No prior chemotherapy or radiation therapy. 10) No anti-platelet drug or anti-coagulant drug at registration.
11) No periodic oral NSAIDs at registration.
12) No history or complication of gastric or duodenal ulcer
13) No history of bronchial asthma.
14) No inflammatory bowel disease and hemorrhagic disease.
15) It is possible to take foods and drugs orally.
16) Within 8 weeks after surgery.
17) Major organ function is preserved. ANC>=3,000/mcl, PLT>=75,000/mcl, T-bil<=2.0 mg/dl, GOT<=100 IU/L, GPT<=100 IU/L , Cr<=1.5 mg/dl
18) The following chemotherapy will be performed as adjuvant chemotherapy.
1.Cpecitabine,2.mFOLFOX6,3.CAPOX
19) Witten informed consent is obtained
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies
2) Infections which needs systemic treatment.
3) Body temperature is higher than 38 degrees centigrade at registration.
4) History of allergy aspirin or salicylic acid.
5) Female during pregnancy, within 28 days of postparturition, or during lactation.
6) Severe psychological disease.
7) Continuous systemic corticosteroid or immunosuppressant treatment.
8) Severe postoperative complicatoins which do not resolve until registration.
9) Regularly using phenytoin.
10) Uncontrollable diabetes mellitus.
11) Uncontrollable hypertension.
12) Unstable angina pectoris, or history of myocardial infarction within 6 months.
Target sample size
880
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hamaguchi |
Organization
Saitama medical university International medical center
Division name
Department of Gastroenterology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama, 350-1298, Japan
TEL
042-984-4111
thamaguc@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Takashima |
Organization
JCOG1503C Coordinating Office
Division name
Gastrointestinal Medical Oncology, National Cancer Center Hospital
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL
03-3542-2511
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
山形県立中央病院(山形県)
群馬県立がんセンター(群馬県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
東京医科歯科大学(東京都)
東邦大学医療センター大橋病院(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
大阪国際がんセンター(大阪府)
関西労災病院(兵庫県)
県立広島病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Advanced Medical Care B
Management information
Registered date
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035650
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