UMIN-CTR Clinical Trial

Basic information
Public title	The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer
Acronym	The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer (APOLLO-11)
Scientific Title	The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer
Scientific Title:Acronym	The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer (APOLLO-11)
Region	Japan

Condition
Condition	Resectable gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess feasibility of preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin, and postoperative adjuvant therapy with TAS-118 alone or TAS-118 plus Oxaliplatin, in patients with resectable locally advanced gastric cancer accompanying lymph node metastasis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Feasibility of preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin and gastrectomy (Step 1/2) -Feasibility of postoperative adjuvant chemotherapy with TAS-118 alone (Step 1) -Feasibility of postoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin (Step 2)
Key secondary outcomes

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	TAS-118/Oxaliplatin
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients satisfying all of the following criteria during baseline observation period will be considered as eligible patients in this study (1)Be confirmed as gastric cancer histopathologically (in any of the histological types) (2)Be diagnosed with cT3-4N1-3M0 on image findings (Japanese Classification of Gastric Carcinoma, 14th Edition) (3)Be with swelling of stomach-regional lymph node of =>8 mm minor axis or =>10 mm major axis (4)Be with no metastasis to Bulky lymph node on CT scanning of upper abdomen (5)Be with no distant metastasis on diagnostic laparoscopy, and negative for peritoneal lavage cytology (6)Be aged of 20-79 years at registration (7)Be with no history of medical treatment to gastric cancer (radiation therapy, chemotherapy,hormone therapy, etc.) (8)Be acceptable for sufficient oral treatment (9)Be with ECOG performance status 0 or 1 (10)Be confirmed that major organic functions are maintained by laboratory test performed within 14 days prior registrationSatisfy the following criteria: -WBC count: => 3000/mm3 and <= 12000/mm3 -Neutrophil count: => 2000/mm3 -Platelet count: => 100000/mm3 -Hemoglobin: => 9.0 g/dL -Total bilirubin: <= 1.5 mg/dL -AST(GOT): <= 100 units/L -ALT(GPT): <= 100 units/L -Serum Creatinine: <= 1.3 mg/dL -CCR: => 60 mL/min (Cockcroft-Gault estimation formula) (11)Be explained about this clinical trial with informed consent form and submitted informed consent in writing
Key exclusion criteria	(1)Be sensitive seriously to ingredients of TAS-118 or Oxaliplatin (2)Be received blood transfusion, blood products and hematopoietic agents such as G-CSF within 2 weeks prior to registration (3)Be under medication with warfarin, phenytoin, flucytosine at registration (4)Have poorly controlled diarrhea (liquid stool, difficult bowel control by medical treatment, => Grade 2, defecation frequency of => 5 times/day, etc.) (5)Have peripheral sensory neuropathy or paraesthesia of => Grade 2 (6)Be with present or past history of sever pulmonary diseases (7)Be with severe (=> Grade 3, etc.) cardiac disease, or experienced cardiac infarction and/or angina within 6 months prior to registration (8)Be with diabetes mellitus poorly controlled by medical therapy or accompanying severe diabetic complications (9)Be with severe (=> Grade 3, etc.) complications (10)Be positive to HIV, or with active hepatitis (11)Be with active infections, inflammatory diseases or collagen diseases (12)Be requiring or receiving continuous systemic administration of steroids (oral or intravenous). (13)Be with active (=> Grade 3, etc.) gastrointestinal hemorrhage (14)Be with simultaneously active multiple primary cancer (simultaneous multiple cancer, and metachronous multiple primary cancers with <= 5 years disease-free period. Carcinoma in situ and lesions corresponding to intra-mucosal carcinoma judged to be cured with local therapy are not included in an active multiple cancer). (15)Females who are pregnant, nursing and possibly pregnant, or not agree to contraception during the administration period and a certain period (6 months) after the final administration of investigational product. Females of childbearing potential must have a negative pregnancy test (16)Be judged difficult to participate in the study due to mental disease or complicating psychiatric symptoms (17)Be judged not to be suitable to participate in the study by principle investigator (co-investigator)
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Kensei Middle name Last name Yamaguchi
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterology Center Gastroenterology medical oncology
Zip code	135-8550
Address	3-8-31 Ariake Koto-ku Tokyo
TEL	03-3520-0111
Email	kensei.yamaguchi@jfcr.or.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Takahari
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterology Center Gastroenterology medical oncology
Zip code	135-8550
Address	3-8-31 Ariake Koto-ku Tokyo
TEL	03-3520-0111
Homepage URL
Email	daisuke.takahari@jfcr.or.jp

Sponsor
Institute	The Cancer Institute Hospital of JFCR
Institute
Department

Funding Source
Organization	TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Yakult Honsha Co.,Ltd.

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

Secondary IDs
Secondary IDs	YES
Study ID_1	TAS-118:28-3587 Oxaliplatin(L-OHP):28-3588
Org. issuing International ID_1	MHLW
Study ID_2
Org. issuing International ID_2
IND to MHLW	TAS-118:2016/11/01 (5) Oxaliplatin:2016/11/01 (15)

Institutions
Institutions	がん研究会有明病院、国立がん研究センター中央病院、聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 11 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	Completed
Date of protocol fixation	2016 Year 08 Month 24 Day
Date of IRB	2016 Year 09 Month 17 Day
Anticipated trial start date	2016 Year 11 Month 18 Day
Last follow-up date	2020 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 07 Month 02 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 02 Day
Last modified on	2020 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028403