UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000638 |
|---|---|
| Receipt number | R000000773 |
| Scientific Title | Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer (OGSG 0402) |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2021/11/15 22:20:27 |
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Basic information
Public title
Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer (OGSG 0402)
Acronym
OGSG0402
Scientific Title
Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer (OGSG 0402)
Scientific Title:Acronym
OGSG0402
Region
| Japan |
Condition
Condition
advanced/recurrent gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A combination of TS-1 plus CPT-11 is compared to that of TS-1 plus CPT-11 in terms of response rate and adverse events for the advanced metastatic gastric cancer as the randomized phase II study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate(RECIS)
Key secondary outcomes
1.Progression free survival (PFS)
2.Overall survival (OS)
3.Adverse Events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: TS-1(80mg/m2/day, between day 1 and 21) + CPT-11(80mg/m2/day, on day and day 15 ) are administered in every 5 weeks (1 course).
Interventions/Control_2
Group B: TS-1(80mg/m2/day between day 1 and 14) + Taxol(50mg/m2/day, on day 1 and 8 ) are administered in every 3 weeks (1 course).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed gastric cancer, histologically
2)with metastatic lesions which can be measured
3) without any prior radiation therapy or chemotherapy using CPT-11, TXL or TS-1
4) Performance Status 0 or 2 in ECOG classification
5) age 20<= and =>75
6) sufficient oral intake
7) Survival period is expected over three months.
8) without any severe disorders in any organs
1. bone marrow function
. WBC: 4,000/mm3<= and > 12,000/mm3
. Neutrocyte: 2,000 /mm3<=
. Hb: 8.0 g/dl <=
. Platelet: 100,000/mm3<=
2. Liver function
. Total Bil.: 1.5 mg>=
. GOT, GPT: < 100 IU/l
3 Renal Function
. Creatinin: 1.2 mg/dl>=
. Creatinin Clearance: 50 mg/mm <= (by Cockcroft-Gault)
9) Written Informed Consents
Key exclusion criteria
1) active double cancer
2) with other severe diseases (ileus, interstitial pneumonia/pulmonary fibrosis, cardiac failure, renal dysfunction, liver dysfunction)
3) with infectious diseases
4) under condition of diarrhea
5) with marked chest or abdominal fluid
6) history of allergy against medicine
7) receiving fluoropyrimidine, antifungal flusitosine or Atazanabil sulfate
8) with gastrointestinal bleeding which needs blood transfusion
9) with liver cirrhosis or jaundice
10) with psychiatric disease which needs medicine
11) with cardiac disease which needs therapy
12) with uncontrolled D M
13) with metastasis to the central nerve system
14) under pregnancy or nursing the baby
15) excluded by doctor due to the other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujitani Kazumasa |
Organization
National Hospital Orgamnzation
Osaka Medical Center
Division name
Dpt.Surgery
Zip code
Address
2-1-14.Houenzaka, chuo-ku, Osaka, 540-0006
TEL
06-6942-1331
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujitani Kazumasa |
Organization
National Hospital Orgamnzation
Division name
Dpt.Surgery
Zip code
Address
2-1-14.Houenzaka, chuo-ku, Osaka, 540-0006
TEL
06-6942-1331
Homepage URL
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
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://ar.iiarjournals.org/content/34/2/851.long
Publication of results
Published
Result
URL related to results and publications
http://ar.iiarjournals.org/content/34/2/851.long
Number of participants that the trial has enrolled
102
Results
The overall response rate (ORR) was determined by the RECIST criteria as, 33.3% (95% Confidence Interval, CI=20.3-47.9) for S-1 plus irinotecan (n=51) compared to 31.4% (95% CI=19.1-45.9) for S-1 plus paclitaxel (n=51), with no statistically significant difference (p=0.841).
PFS was 173 days for S-1 plus irinotecan compared with 141 days for S-1 plus paclitaxel (HR=1.18, p=0.421).
The median survival time (MST) was 379 days for S-1 plus irinotecan and 364 days for S-1 plus paclitaxel (HR=0.988, p=0.956) .
Results date posted
| 2021 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2014 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Patients were required to have histologically-proven unresectable advanced or recurrent gastric cancer with measurable lesions
Participant flow
Between December 2004 and November 2007, a total of 102 patients (S-1 plus irinotecan, n=51; S-1 plus paclitaxel, n=51) were enrolled from 13 Institutions and randomized. Two patients died before the initiation of treatment and one patient was lost to follow-up (S-1 plus irinotecan).
Adverse events
The incidence of major hematological toxicities was higher with S-1 plus irinotecan than with S-1 plus paclitaxel. Grade 3 or 4 neutropenia was observed in only 2% of patients treated with S-1 plus paclitaxel versus 19% of patients treated with S-1 plus irinotecan, while the corresponding incidences of febrile neutropenia were 2% vs. 0%, respectively. The most common grade 3 or 4 non-hematological toxicities were diarrhea (S-1 plus irinotecan vs. S-1 plus paclitaxel, 6% vs. 2%), anorexia (13% vs. 10%), nausea, and vomiting (4% vs. 6%). There were no treatment-related deaths in either arm.
Outcome measures
The primary end-point was the overall response rate (ORR). Secondary end-points were progression-free survival (PFS), overall survival (OS), and safety.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 15 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000773
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