UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of weekly paclitaxel patients with pre-treatment (2 regimens) advanced/recurrent gastric cancer (OGSG 0602)
Acronym	OGSG 0602
Scientific Title	Feasibility study of weekly paclitaxel patients with pre-treatment (2 regimens) advanced/recurrent gastric cancer (OGSG 0602)
Scientific Title:Acronym	OGSG 0602
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 phase II study, that the feasibility and response of TS-1 + CPT-11 for advanced and/or recurrent gastric cancer as the third line therapy are evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	feasibility of the treatment (ratio of completion)
Key secondary outcomes	Incidence of adverse events, Response Rate,Time to treatment failure,Progression free survival, Overall survival

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	Premedication: Dexamethazon 20mg should be administered 30 minutes before Paclitaxel therapy Paclitaxel is administered on day 1, 8, and day 15 in one course of 28 days. It will be repeated until treatment stop.
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	1. histologically proven gastric carcinoma 2. patients who received TS-1 or CPT-11 as a prior chemotherapy and enough treatment free period (TS-1: 2weeks, CPT-11: 2weeks) 3. with measurable lesions 4. age: 20<= years old 5. PS(ECOG): 0 &#8211; 2 6. without any other severe diseases WBC 3,000<= Neutrocyte 1,500mm3<= Hemoglobin 9.0 g.dl <= Platelet 100,000/mm3 <= Total bilirubin 1.5 mg/dl => AST, ALT within five times of normal range in each institute Serum creatinin 1.5 mg/dl >= ECG normal range 7. expected survival period: longer than 3 months 8. written informed consents
Key exclusion criteria	1. cavity fluid which should be taken out 2. with double cancer and/or multiple cancer 3. patients with disorders on peripheral nerves 4. with active infectious disease which needs treatment 5. under the condition of diarrhea 6. with some mental and/or neural disorder which disturbs registration 7. under continuous steroids therapy 8. with other severe diseases(intestinal paralysis, intestinal obstruction, uncontrolled DM, pulmonary fibrosis, cardiac failure, or liver dysfunction) 9. pregnant and/or nursing women 10.with allergic history against medicines 11.with severe allergic response against medicine including cremoful 12.under Docetaxel or Paclitaxel therapy 13.doctors' stop not to register to the study
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Middle name Last name Taro Sato
Organization	Kinki University school of medicine
Division name	Dpt. Oncology
Zip code
Address	377-2 Oono-higashi, Osakasayama-shi, Osaka 589-8511
TEL	072-366-0221
Email

Public contact
Name of contact person	1st name Middle name Last name Furukawa Hiroshi
Organization	Sakai City Hospital
Division name	Director
Zip code
Address	1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL	072-221-1700
Homepage URL
Email

Sponsor
Institute	OGSG
Institute
Department

Funding Source
Organization	NPO Osaka Chinical 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 06 Month 01 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	2006 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date	2006 Year 09 Month 01 Day
Last follow-up date	2009 Year 09 Month 01 Day
Date of closure to data entry	2009 Year 09 Month 01 Day
Date trial data considered complete	2009 Year 09 Month 01 Day
Date analysis concluded	2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 05 Month 24 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=R000000865