UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006378
Receipt number 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 15:30:26

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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 or person

Institute

non-profit organization KSATTS

Institute

Department

Personal name



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

Value
https://center6.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