UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003962
Receipt number R000004769
Scientific Title Neoadjuvant Chemotherapy for locally advanced gastric cancer with S-1/weekly cisplatin
Date of disclosure of the study information 2010/07/28
Last modified on 2010/07/28 12:21:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Neoadjuvant Chemotherapy for locally advanced gastric cancer with S-1/weekly cisplatin

Acronym

Neoadjuvant Chemotherapy for advanced gastric cancer with S-1/weekly cisplatin

Scientific Title

Neoadjuvant Chemotherapy for locally advanced gastric cancer with S-1/weekly cisplatin

Scientific Title:Acronym

Neoadjuvant Chemotherapy for advanced gastric cancer with S-1/weekly cisplatin

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Progress in treatment for advanced gastric cancers - Evaluating antitumor effect, safety and influence on surgical operation of the preoperative dosage of the S-1/weekly cisplatin combination therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Antitumor effect before surgery,
Safety of neoadjuvant chemotherapy,
Safety of surgery after neoadjuvant chemotherapy,
Adverse event during surgical operation

Key secondary outcomes

Histological antitumor effect,
Type of recurrence,
Recurrence-free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Neoadjuvant chemotherapy of S-1/weekly cisplatin
followed by surgical operation

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Gastric cancer confirmed by histology or cytology
2. Stage II, IIIA or IIIB (T2 or more) by preoperative diagnosis
3. Resectable with surgical operation
4. Tumor lesion able to be measured or evaluated
5. Performance Status (ECOG) 0-1

Key exclusion criteria

1. Suspect of peritoneum dissemination
2. Severe medical condition
3. Active bleeding from gastrointestinal tract
4. Poor oral intake
5. Malignant tumor of other organs
6. Contraindication for S-1 or cisplatin

Target sample size

34


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sachiyo Nomura MD, PhD

Organization

The University of Tokyo Hospital

Division name

Gastrointestinal Surgery

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN

TEL

03-3815-5411

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Nozaki MD, PhD

Organization

The University of Tokyo Hospital

Division name

Clinical Research Support Center

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN

TEL

03-3815-5411

Homepage URL


Email

knozaki-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

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

2010 Year 07 Month 28 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

Open public recruiting

Date of protocol fixation

2006 Year 04 Month 12 Day

Date of IRB


Anticipated trial start date

2006 Year 04 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

2010 Year 07 Month 28 Day

Last modified on

2010 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004769


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name