UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006872
Receipt number R000008118
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)
Date of disclosure of the study information 2011/12/12
Last modified on 2021/11/23 22:16:59

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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 or person

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008118