UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of second-line chemotherapy using CPT-11 plus CDDP in patients with advanced/recurrent gastric cancer (OGSG 0504)
Acronym	OGSG0504
Scientific Title	Phase II study of second-line chemotherapy using CPT-11 plus CDDP in patients with advanced/recurrent gastric cancer (OGSG 0504)
Scientific Title:Acronym	OGSG0504
Region	Japan

Condition
Condition	Advanced/Recurrent gastric cancer which has no response to S-1
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A phase II study to evaluate the effectiveness and feasibility of CPT-11 + CDDP for patients with advanced/recurrent gastric cancer which has no response to S-1
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Antitumor response (Response Rate, Duration of response)
Key secondary outcomes	1) Adverse Events 2) Overall survival 3) Progression free survival;PFS 4) Time to treatment failure;TTF 5) Relative dose intensity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CPT-11(60mg/m2) and CDDP(30mg/m2) are administered on day 1, 15, 29, and 43, and more courses on every 14 days if patients can be tolerant and have response (effective). One course takes 14 days. ______________Day 1__________Day 15 CPT-11___60mg/m2______60mg/m2 CDDP______30mg/m2______30mg/m2
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. gastric carcinoma diagnosed histologically 2. advanced and/or recurrent gastric cancer 3. gastric cancer which has no response to prior TS-1 therapy a. progression during or after TS-1 therapy b. recurrence within 26 weeks of the end of postoperative TS-1 therapy 4. without surgical operation or any therapies other than TS-1 5. with TS-1 therapy more than 4 weeks 6. more than 4 weeks rest after TS-1 therapy 7. with measurable lesion 8. age between 20 and 75 years old 9. Performance Status 0-2 (ECOG Classification) 10. more than 13 weeks of expected survival 11. with good function in the important organs WBC: 4,000 <= and =>12,000/mm3 Neutrophil >= 2,000/mm3 Platelet >= 100,000 /mm3 Hb >= 8.0 g/dl sGOT, sGPT: < normal range x 2.5 T Bil.: <= 1.5 mg/dl sCreatinin <=Clearlance 12. written informed consent
Key exclusion criteria	1. with interstitial pneumonitis or pulmonary fibrosis 2. much fluid in the cavity 3. active double cancer except carcinoma in situ or skin cancer 4. with infectious disease which needs treatment 5. intestinal paralysis or ileus 6. watery stool (diarrhea) 7. uncontrolled DM or DM being treated by insulin 8. with ischemic cardiac disease 9. with psycologic disorder which disturbs recruiting to the study 10. with severe diseases (cardiac failure, liver dysfunction or renal dysfunction) 11. pregnant and/or nursing women 12. present and/or past allergy against medicines 13. doctor's decision not to recruit to the study
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hirao Motohiro
Organization	National Hospital Organization Osaka National Hospital
Division name	Dpt.Surgery
Zip code
Address	2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL	06-6942-1331
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	National Hospital Orgamnzation
Division name	Dpt.Surgery
Zip code
Address	2-1-14,Houenzaka,Chuou-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 05 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date	2005 Year 06 Month 01 Day
Last follow-up date	2007 Year 08 Month 01 Day
Date of closure to data entry	2007 Year 08 Month 01 Day
Date trial data considered complete	2008 Year 08 Month 01 Day
Date analysis concluded	2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 04 Month 26 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=R000000830