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 |
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)
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)
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)
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)
Japan |
Gastric Cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
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.
Others
feasibility
Exploratory
Pragmatic
Phase II
70% of Relative Performance (RP) of TS-1
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
70
1st name | |
Middle name | |
Last name | Hiroshi Imamura |
Toyonaka City Hospital
Department of Surgery
4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
06-6843-0101
imamurahiroshisakai@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hiroshi Furukawa |
Kinki University School of Medicine
Department of surgery
377-2, Onohigashi, Osakasayama, Osaka, Japan
072-366-0221
hiroshi.furukawa@tokushukai.jp
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Osaka Clinical Study Supporting Organization
Self funding
NO
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)
2011 | Year | 12 | Month | 12 | Day |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560593/
Published
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560593/
82
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.
2021 | Year | 11 | Month | 23 | Day |
2021 | Year | 07 | Month | 16 | Day |
patients receiving postoperative adjuvant chemotherapy
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.
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%).
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.
Completed
2011 | Year | 10 | Month | 31 | Day |
2012 | Year | 01 | Month | 23 | Day |
2012 | Year | 02 | Month | 08 | Day |
2015 | Year | 07 | Month | 23 | Day |
2016 | Year | 01 | Month | 18 | Day |
2011 | Year | 12 | Month | 11 | Day |
2021 | Year | 11 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008118