UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Acronym	A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Scientific Title	A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Scientific Title:Acronym	A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A feasibility of TS-1 plus Elental administration, relative performance of the TS-1 and the nutrition condition are to be studied in this phase II trial.
Basic objectives2	Others
Basic objectives -Others	feasibility
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	70% of Relative Performance (RP) of TS-1
Key secondary outcomes	1)Nutrition Indicator : Body Weight, BMI, s-Albumin, s-Protein, s-Cholesterol 2)PR of TS-1 on 8 courses 3)AE of TS-1 4)PR of Elental 5)Ratio of patients who were tolerant to the test dose of Elental

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	Tolerance Test of Elental 1)Patients take Ellental during 14 days after the start of oral intake. 2)A 100Kcal of Elental is administered three times between each meal (total 300Kcal/day) = test dose 3)Results : Tolerant : Patients who can take over 60% or more of test dose can be registered fot second registration Treatment Schedule A total of 300Kcal/day of Elental is administered for 42 days as one course. Four courses administration is required and additional courses is permitted (maximum 365 days) One Course : TS-1 continuous administration for 28 days, after 14 days rest. Elental continuous administration for 42 days.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligebility Criteria during hospital stat 1)patients 20 years old or more 2)proven gastric cancer histlogecally 3)Stage II or Stage III confirmed by R0 surgery 4)PS (ECOG) between 0 and 2 5)wityout any prior chemotherapy and/or radiation therapy 6)with good oral intake 7)written informed consent to participate in this study 8)without any postoperative complications Eligebility criteria after discharge (second registration) Patients registerd in hospital are rechecked for the second registration 1)Stage II (except patients T1 or T3/N0) or Stage III diagnosed at the surgical operation and/or intra-peritoneal cytological examination 2)Patients who can take 60% or more of the test dose of Elental 3)without any severe diseases and with a good condition of important organs for administration of TS-1 a)WBC >= 2,500/mm3 b)neutrophil >= 1,200/mm3 c)platelet >=75,000/mm3 d)hemoglobin >= 8.0g/L e)AST/ALT <= 100 IU/L f)total bilirubin <= 1.5mg/dL g)Creatinin clearance >= 40ml/min CC by Cockcroft-Gault method is avilable
Key exclusion criteria	Exclusion Criteria duriong hospital stay 1)with active double cancer (*) *Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years. Carcinoma in situ or cancers localized in membranous layer are not included to double cancer. Cancers removed by EMR/ESD are included. 2)with a history of allergy against TS-1 and/or Elental 3)with active infection diseases 4)with uncontrollable hypertension 5)with uncontrollable DM 6)with severe heart diseases clinically 7)with severe lung diseases (interstitial pneumonitis,pulmonary fibrosis, or pulmonary emphysema) 8)with psychologic diseases and/or psychological symptpms 9)women pregnant and/or nursing or women who like to be pregnant 10)patient registered to the other study whose endpoints are same to This study. 11)patients whom doctor decide not to register to this study
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Imamura
Organization	Toyonaka City Hospital
Division name	Department of Surgery
Zip code
Address	4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL	06-6843-0101
Email	imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Furukawa
Organization	Kinki University School of Medicine
Division name	Department of surgery
Zip code
Address	377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL	072-366-0221
Homepage URL
Email	hiroshi.furukawa@tokushukai.jp

Sponsor
Institute	Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization	Self funding
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	八尾市立病院(大阪府)、大阪府急性期総合医療センター(大阪府)、東大阪市立総合病院(大阪府)、市立豊中病院(大阪府)、市立堺病院(大阪府)、関西医科大学枚方病院(大阪府)、北野病院(大阪府)、JCHO大阪病院(大阪府)、星ヶ丘厚生年金病院(大阪府)、日生病院(大阪府)、大阪医療センター(大阪府)、市立貝塚病院(大阪府)、大阪警察病院(大阪府)、西宮市立中央病院(兵庫県)、大阪府立成人病センター(大阪府)、神戸大学(兵庫県)

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 12 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560593/
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560593/
Number of participants that the trial has enrolled	82
Results	Primary endpoint: S-1 completion rate In the PPS, the S-1 completion rate was 69.0% (95% CI: 56.9-79.5). When stratified by surgical method, S-1 completion rates were 68.0% (95% CI: 46.5-85.1) for TG and 69.6% (95% CI: 54.2-82.2) for DG.
Results date posted	2021 Year 11 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 07 Month 16 Day
Baseline Characteristics	patients receiving postoperative adjuvant chemotherapy
Participant flow	From February 2012 to July 2014, 149 patients with clinical stage II or III GC after R0 were registered in the first stage and began the OENS compliance test. Twenty-six patients did not show acceptability (>60% intake) of the OENS in the test for at least 14 days. The compliance with the OENS of all patients registered in the first stage was 82.3% (95% CI: 77.5-87.2). Twenty-one patients did not have GC in pathological stage II or III. A total of 82 patients met the eligibility criteria for the second registration. Excluding one patient who was found to be ineligible after registration (due to a history of bladder cancer and treatment), 81 patients were included in the FAS. Of those, after excluding 10 patients who had a recurrence during adjuvant chemotherapy, 71 patients were included in the PPS, and 51 completed 1 year of treatment.
Adverse events	Overall, 13 patients had >= 1 AE during the first registration period (diarrhea, n = 9; abdominal pain, n = 5; vomiting, n = 2; anorexia and fatigue, n = 1 each). All AEs were Grade =< 2, and none were found to be clinically significant according to the investigator's judgment. The AE profile for the FAS population is shown in Table 4. The overall incidence of AEs of any Grade was 98.8%. The incidence of Grade 3 or 4 AEs was 22/81 (27.2%), with neutropenia (12.3%) the most commonly observed, followed by anorexia (3.7%), diarrhea (3.7%), and nausea (1.2%).
Outcome measures	The primary endpoint was the S-1 completion rate for 1 year with a relative performance (RP) value of>= 70%; secondary endpoints included factors affecting the completion rate of S-1, RP value after eight S-1 courses, S-1 and OENS persistence rates, nutritional index, OENS compliance, and safety.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 31 Day
Date of IRB	2012 Year 01 Month 23 Day
Anticipated trial start date	2012 Year 02 Month 08 Day
Last follow-up date	2015 Year 07 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 01 Month 18 Day

Other
Other related information

Management information
Registered date	2011 Year 12 Month 11 Day
Last modified on	2021 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008118