UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002595 |
|---|---|
| Receipt number | 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 09:19:53 |
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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
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
yoshikawat@kcch.jp
Sponsor or person
Institute
COMPASS research group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003170
