UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027280 |
|---|---|
| Receipt number | R000029677 |
| Scientific Title | Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD) |
| Date of disclosure of the study information | 2017/05/09 |
| Last modified on | 2018/02/14 14:31:23 |
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Basic information
Public title
Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD)
Acronym
Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD)
Scientific Title
Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD)
Scientific Title:Acronym
Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD)
Region
| Japan |
Condition
Condition
small bowel adenocarcinoma
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the superiority in terms of relapse-free survival (RFS) of post-operative CAPOX therapy to observation for curative resected pathological stage I/II/III small bowel adenocarcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
overall survival, disease-free survival (DFS defined by JCOG), disease-free survival (DFS defined by IRCI), adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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: Observation. Patients are observed without treatment until relapse occurs.
Interventions/Control_2
B: CAPOX therapy. Patients receive 8 courses of CAPOX therapy (capecitabine 2,000 mg/m2 day1-14, oxaliplatin 130 mg/m2 day1) every 3 weeks.
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
| 16 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven adenocarcinoma of which primary tumor is located in the duodenum, jejunum, or ileum (adenocarcinoma of the papilla of Vater is ineligible, but primary duodenal adenocarcinoma which histologically invade to the papilla of Vater is eligible).
2) R0 resection is achieved by small bowel resection, pancreaticoduodenectomy, or distal gastrectomy with regional lymph nodes dissection.
3) Lavage Cytology during surgery is negative, unknown, or unexamined (Only positive case is ineligible).
4) Pathological stage is stage I (T1bN0M0 or T2N0M0), stage II, or stage III.
5) Aged between 16 and 74 years
6) ECOG performance status (PS) of 0 or 1
7) Sufficient oral intake
8) No metastasis/relapse findings on chest CT and enhanced abdomen-pelvis CT/MRI performed within 84 days before registration.
9) No history of chemotherapy or radiotherapy for small bowel adenocartinoma.
10) No history of platinum usage (ex. cisplatin, carboplatin, oxaliplatin, nedaplatin).
11) From 28 days to 84 days after surgery
12) Sufficient organ function
13) Written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies
2) Active infection requiring systemic therapy.
3) Body temperature of 38 degrees Celsius or higher.
4) Female during pregnancy, within 28 days of postparturition, or during lactation.
5) Severe psychological disease.
6) Continuous systemic corticosteroid or immunosuppressant treatment.
7) Inflammatory bowel disease (ex. Crohn disease, ulcerative colitis) or malabsorption (ex. Celiac disease) requiring therapy.
8) Uncontrollable diabetes mellitus
9) Uncontrollable hypertension
10) Unstable angina pectoris, or history of myocardial infarction within 6 months.
11) Positive HIV antibody.
12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihide Kanemitsu |
Organization
National Cancer Center Hospital
Division name
Colorectal Surgery Division
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
ykanemit@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Honma |
Organization
JCOG1502C Coordinating Office
Division name
National Cancer Center Hospital Gastrointestinal Medical Oncology Division
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
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
National Cancer Center
Organization
Division
Category of Funding Organization
Other
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
栃木県立がんセンター（栃木県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（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）
東海大学医学部（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
金沢大学医学部（石川県）
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）
国立病院機構大阪医療センター（大阪府）
大阪医科大学（大阪府）
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）
国立病院機構九州がんセンター（福岡県）
熊本大学医学部（熊本県）
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 09 | 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
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2031 | Year | 11 | Month | 09 | 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
| 2017 | Year | 05 | Month | 09 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029677
