UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031388
Receipt number R000034119
Scientific Title Pilot study of neoadjuvant chemotherapy with S-1 and oxaliplatin clinical Stage III gastric cancer
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/20 16:08:34

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Basic information

Public title

Pilot study of neoadjuvant chemotherapy with S-1 and oxaliplatin clinical Stage III gastric cancer

Acronym

Pilot study of neoadjuvant chemotherapy with S-1/oxaliplatin in clinical Stage III gastric cancer

Scientific Title

Pilot study of neoadjuvant chemotherapy with S-1 and oxaliplatin clinical Stage III gastric cancer

Scientific Title:Acronym

Pilot study of neoadjuvant chemotherapy with S-1/oxaliplatin in clinical Stage III gastric cancer

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of S-1 and oxaliplatin as neoadjuvant chemotherapy for the clinical Stage III gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Response rate

Key secondary outcomes

Completion rate of neoadjuvant chemotherapy
Completion rate of adjuvant chemotherapy
Pathological response rate
Incidence of adverse events of neoadjuvant chemotherapy
Incidence of postoperative complications
R0 resection rate
Progression-free survival
Overall survival
Completion rate of laparoscopic surgery


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 Maneuver

Interventions/Control_1

S-1:80-120mg/body/day,PO,day1-14,
Oxaliplatin:130 mg/m2, IV day1, every 21 days for 2 cycles followed by D2 surgery

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric
adenocarcinoma
2) Clinical Stage III gastric cancer
3) Age above 20 years old
4) ECOG performance status of 0 or 1
5) No previous chemotherapy,radiation
therapy or surgery for gastric cancer
6) Adequate organ function
1. WBC:>=3,000/mm3,<12,000/mm3
2. Neutrophil:>=1,500/mm3
3. Platelet:>=100,000/mm3
4. Hemoglobin:>=9.0g/dL
5. AST(GOT)/ALT(GPT):<=100 IU/L
6. Total bilirubin:<=2.0mg/dL
7. Serum creatinine:<=1.2mg
8. Creatinine clearance:>=60 mL/min
7) Possible oral intake
8) Written informed consent from patient

Key exclusion criteria

1) With active double or multiple cancers
2) Severe complications
3) With active infection
4) Past history of severe hypersensitivity to drugs
5) Under treatment with flucytosine
6) Under treatment with warfarin
7) Pregnant women, or women with the
possibility of the pregnancy, Men who want let to pregnancy
8) Patients judged inappropriate for the study by the physicians

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sayuri Konishi

Organization

Kyoto Katsura Hospital

Division name

Department of Surgery, Gastro-Intestinal Center

Zip code


Address

17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan

TEL

075-391-5811

Email

d_manaka@katsura.com


Public contact

Name of contact person

1st name
Middle name
Last name Sayuri Konishi

Organization

Kyoto Katsura Hospital

Division name

Department of Surgery, Gastro-Intestinal Center

Zip code


Address

Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan

TEL

075-391-5811

Homepage URL


Email

sayurik0713@gmail.com


Sponsor or person

Institute

Kyoto Katsura Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

2018 Year 02 Month 20 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

No longer recruiting

Date of protocol fixation

2016 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 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

2018 Year 02 Month 20 Day

Last modified on

2018 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name