UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002595
Receipt No. R000003170
Scientific Title Comparison of multimodality treatment; 2 or 4 courses of Paclitaxel/CDDP or S1/CDDP followed by surgery for locally advanced gastric cancer, a randomized phase II trial (COMPASS)
Date of disclosure of the study information 2009/10/07
Last modified on 2017/04/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of multimodality treatment; 2 or 4 courses of Paclitaxel/CDDP or S1/CDDP followed by surgery for locally advanced gastric cancer, a randomized phase II trial
(COMPASS)
Acronym Neoadjuvant chemotherapy for advanced gastric cancer
Scientific Title Comparison of multimodality treatment; 2 or 4 courses of Paclitaxel/CDDP or S1/CDDP followed by surgery for locally advanced gastric cancer, a randomized phase II trial
(COMPASS)
Scientific Title:Acronym Neoadjuvant chemotherapy for advanced gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to clarify the safety and efficacy of multimodality treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Survival rate at three years
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 courses of neoadjuvant chemotherapy of S1+CDDP followed by surgery
Interventions/Control_2 4 courses of neoadjuvant chemotherapy of S1+CDDP followed by surgery
Interventions/Control_3 2 courses of neoadjuvant chemotherapy of paclitaxel+CDDP followed by surgery
Interventions/Control_4 4 courses of neoadjuvant chemotherapy of paclitaxel+CDDP followed by surgery
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Adenocarcinoma of the stomach confirmed by endscopic biopsy
2. Macroscopically resectable stage 3/4 gastric cancer or stage 2 of schirrhous type/tumors invading esophagus
3. M0
Key exclusion criteria 1. Severe medical condition
2. Malignant tumors of other organs
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaki Yoshikawa
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan
TEL 045-391-5761
Email yoshikawat@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaki Yoshikawa
Organization Kanagawa Cancer Center
Division name Department of Gastrointesitnal Surgery
Zip code
Address 1-1-2 Nakao Asahi-Ku, Yokohama 241-0815, Japan
TEL 045-391-5761
Homepage URL
Email yoshikawat@kcch.jp

Sponsor
Institute COMPASS research group
Institute
Department

Funding Source
Organization Non profit organization ECRIN
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2016 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 07 Day
Last modified on
2017 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.