UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013109
Receipt number R000015292
Scientific Title Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
Date of disclosure of the study information 2014/02/21
Last modified on 2022/08/17 12:07:00

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Basic information

Public title

Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients

Acronym

GAPS study

Scientific Title

Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients

Scientific Title:Acronym

GAPS study

Region

Japan


Condition

Condition

serosa positive gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

percent completion of protocol treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intraperitoneal and intravenous Paclitaxel plus TS-1

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

(i) Histologically proven common gastric carcinoma
(ii) Suspected serosa invasive gastric cancer
(iii) There must be an absence of peritoneal metastasis or negative finding from peritoneal washing cytology confirmed by staging laparoscopy
(iv) The patient must have clinically resectable gastric cancer
(v) Tumor invasion of the esophagus must be less than 3 cm,
(vi) Patients must be in the age range 20-75 years
(vii) The Eastern Cooperative Oncology Group performance status must be 0 or 1
(viii) No previous therapy against GC should have been carried out, and no previous chemotherapy, CRT or radiotherapy
(ix) No typical bleeding from GC and stenosis of gastro-intestinal tract should have occurred
(x) Sufficient oral intake is required
(xi) Written informed consent will be obtained from all patients
(xii) Adequate organ functions are required

Key exclusion criteria

(i) The occurrence of simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor that is curable with local therapy
(ii) A history of severe drug hypersensitivity
(iii) The presence of active bacterial or fungal infection, and a body temperature over 38 temperature.
(iv) Pregnancy or lactation in women of childbearing potential
(v) Men who wish the partners pregnancy
(vi) The presence of unstable angina, heart failure or a history of myocardial infarction within 6 months
(vii) Patients requiring systemic steroid medication
(viii) Patients requiring the administration of phenytoin or warfarin potassium
(ix) The presence to peptic ulcer or bleeding
(x) The presence of severe diarrhea
(xi) The presence of antigen-positive serum HBs and/or antibody positive serum HVC
(xii) The presence of uncontrollable intestinal paralysis, interstitial pneumonitis or ischemic heart disease
(xiii) Patients determined to be inappropriate for this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Motohiro
Middle name
Last name Imano

Organization

Kinki University Faculty of Medicine

Division name

Department of Surgery

Zip code

5898511

Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan

TEL

072-366-0221

Email

imano@med.kindai.ac.jp


Public contact

Name of contact person

1st name Motohiro
Middle name
Last name Imano

Organization

Kinki University Faculty of Medicine

Division name

Department of Surgery

Zip code

5898511

Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan

TEL

072-366-0221

Homepage URL


Email

imano@med.kindai.ac.jp


Sponsor or person

Institute

Intraperitoneal chemotherapy study group

Institute

Department

Personal name



Funding Source

Organization

Intraperitoneal chemotherapy study group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kindai University

Address

377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan

Tel

072-366-0221

Email

imano@med.kindai.ac.jp


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

2014 Year 02 Month 21 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

Completed

Date of protocol fixation

2014 Year 02 Month 20 Day

Date of IRB

2014 Year 01 Month 08 Day

Anticipated trial start date

2014 Year 05 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 08 Day

Last modified on

2022 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015292


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name