UMIN-CTR Clinical Trial

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
Email

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
Email

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000773