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Recruitment status Terminated
Unique ID issued by UMIN UMIN000008941
Receipt No. R000010483
Scientific Title Phase I/II trial of neoadjuvant S-1/CDDP with concurrent radiation for locally Advanced gastric cancer
Date of disclosure of the study information 2012/09/19
Last modified on 2015/04/21

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Basic information
Public title Phase I/II trial of neoadjuvant S-1/CDDP with concurrent radiation for locally Advanced gastric cancer
Acronym Phase i/II trial of neoadjuvant chemoradiotherapy for locally Advanced gastric cancer
Scientific Title Phase I/II trial of neoadjuvant S-1/CDDP with concurrent radiation for locally Advanced gastric cancer
Scientific Title:Acronym Phase i/II trial of neoadjuvant chemoradiotherapy for locally Advanced gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I
Primary objective is to estimate the maximum tolerated dose (MTD) and recommended dose (RD) of neoadjuvant chemoradiotherapy of S-1 with CDDP for locally advanced gastric cancer.
Phase II
Primary objective is to estimate the pathological response rate when administered at recommended dose estimated in Phase I.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Phase I
estimate the maximum tolerated dose (MTD)and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP
Phase II
Pathological response rate
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 [Phase I]
S-1 with CDDP neoadjuvant chemoradiotherapy is conducted. S-1 is orally administered for 14 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15. Radiation is delivered a dose of 40 Gy (20 fractions of 2.0 Gy) during 4 weeks.

[Phase II]
At the first course of neoadjuvant TS-1/CDDP with concurrent radiotherapy, TS-1/CDDP is administered at the second course. After more than 3 weeks from last administration of chemotherapy, gastrectomy is executed.
At the chemoradiotherapy, S-1 is orally administered for 14 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15. Radiation is delivered a dose of 40 Gy (20 fractions of 2.0 Gy) during 4 weeks.
At the chemotherapy, S-1 is orally administered for 28 days followed by 14 days rest according to body surface area. CDDP 20mg/m2 is administered intravenously at day 1, 15, 29.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) confirmed gastric cancer by endscopic biopsy
2) eligible to below
i) clinico pathological clasification type is 3 or 4.
ii) has advanced lymph node metastasis
3) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology
4) esophagus invation <= 3cm
5) age: >=20 and <80
6) P.S. 0 or 1
7) No prior treatment
8) possible to oral intake
9) sufficient function of important organs
10) written informed consent
Key exclusion criteria 1) known sever drug allergies
2) with clinically important infection
3) with diarrhea
4) with intestinal paralysis or ileus
5) with interstitial pneumonia or pulmonary fibrosis
6) has history of radiation to chest or ilium
7) has active carcinoma
8) with uncontrollable diabetes mellitus
9) has complication which is clinically probrem
10) with clinically important mental disorder need to treat
11) pregnant or nursing women or women who like be pregnant and willing to get pregnant
12) administered flucytosine
13) being blood transfusion or need to blood transfusion
14) doctor's decision not to be registered to this study
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email tsunehiro-t@a8.keio.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization School of Medicine, Keio University
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
2012 Year 09 Month 19 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 Terminated
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 19 Day
Last modified on
2015 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010483


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