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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006378
Receipt No. R000007525
Scientific Title Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial
Date of disclosure of the study information 2011/09/21
Last modified on 2019/01/24

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Basic information
Public title Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial
Acronym COMPASS-D trial
Scientific Title Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial
Scientific Title:Acronym COMPASS-D trial
Region
Japan

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

Objectives
Narrative objectives1 he present study aims to evaluate effficacy and safety of neoadjuvant chemotherapy among 2 and 4 courses of S-1/CDDP and S-1/CDDP/Docetaxel followed by curative surgery and adjuvant chemotherapy with S-1 in locally advanced gastric cancer patients who have poor prognosis without neoadjuvant chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Three-year overall survival rate
Key secondary outcomes overall survival,
progression-free survival, pathological response,
clinical response,
R0 resection rate,
R0R1 resection rate,
completion rate of neoadjuvant chemotherapy, incidence of adverse events, and these parameters in each subset

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 courses of S-1/CDDP
Interventions/Control_2 4 courses of S-1/CDDP
Interventions/Control_3 2 courses of S-1/CDDP/Docetaxel
Interventions/Control_4 4 courses of S-1/CDDP/Docetaxel
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 i. Histologically proven adenocarcinoma of the stomach
ii. Clinical T4, or T3 disease in cases of tumors invading the esophagus or of the schirrhous type including giant type 3 with a maximal diameter of more than 8 cm, confirmed by abdominal CT and laparoscopy. The T and N stages are determined according to the method proposed by Haberrmann.
iii. No pleural effusion, no ascites exceeding pelvis, and no metastasis to the peritoneum, liver, or other distant organs, confirmed by abdominal-pelvic CT.
iv. No metastasis to the lung, mediastinal lymph nodes, or the other distant organs, confirmed by thoracic CT for tumors invading the esophagus.
v. No clinically apparent distant metastasis
vi. Age ranging between 20 and 80.
vii. ECOG performance status 0-1
viii. Enough oral intake
ix. No previous treatment with chemotherapy or radiation therapy for any tumors
x. No previous surgery for the present disease except bypass surgery
xi. Sufficient organ functions
xii. Written informed consent.
Key exclusion criteria i. Remnant stomach cancer
ii. Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included).
iii. Females with an on-going pregnancy or breast-feeding, or who are contemplating pregnancy.
iv. Mental disorders which may affect the ability or willingness to provide informed consent or abide by the study protocol
v. Systemic treatment with a corticosteroid
vi. Systemic treatment with flucytosine, phenytoin, or warfarin potassium
vii. Allergic reaction to iodine
viii. Hypersensitivity to docetaxel, cisplatin, or polysorbate 80
ix. Peripheral neuropathy
x. Edema
xi. Pneumonitis, lung fibrosis, or emphysema in need for oxygen therapy
xii. Active inflammation due to bacteria or fungus
xiii. Unstable angina or cardiac infarction within 6 months
xiv. Positive for HBs antigen or HCV antibody
xv. Unstable hypertension
xvi. Diabetes mellitus under treatment.
Target sample size 120

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
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 Gastrointestinal Surgery
Zip code
Address 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815
TEL 045-391-5761
Homepage URL
Email yoshikawat@kcch.jp

Sponsor
Institute non-profit organization KSATTS
Institute
Department

Funding Source
Organization non-profit organization KSATTS
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 神奈川県立がんセンター(神奈川県)
聖マリアンナ医科大学(神奈川県)
北里大学東病院(神奈川県)
昭和大学藤が丘病院(神奈川県)
愛知県がんセンター中央病院(愛知県)
福井県済生会病院(福井県)
大阪府立急性期・総合医療センター(大阪府)
広島市立安佐市民病院(広島県)
NTT西日本大阪病院(大阪府)
広島大学病院(広島県)
愛知県がんセンター愛知病院(愛知県)
神戸市立医療センター中央市民病院(兵庫県)
市立堺病院(大阪府)
国立病院機構大阪医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Gastrointestinal Cancer Symposium 2019 
(ASCO-GI 2019)
2019/1/17


Considering high 3-year OS, four courses DCS has a value to be tested in a future phase III study to confirm superiority of neoadjuvant chemotherapy for locally advanced gastric cancer. 
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
2011 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 12 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
2011 Year 09 Month 21 Day
Last modified on
2019 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007525

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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