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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027280
Receipt No. 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

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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
Email 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/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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