UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD)
Title of the study (Brief title)	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	Yukihide Kanemitsu
Organization	National Cancer Center Hospital
Division name	Colorectal Surgery Division
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	ykanemit@ncc.go.jp

Public contact
Name of contact person	Yoshitaka Honma
Organization	JCOG1502C Coordinating Office
Division name	National Cancer Center Hospital Gastrointestinal Medical Oncology Division
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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