UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023620
Receipt number R000027201
Scientific Title Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Date of disclosure of the study information 2016/10/01
Last modified on 2024/02/19 09:05:08

* 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

Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology

Acronym

PR-PHOENIX trial

Scientific Title

Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology

Scientific Title:Acronym

PR-PHOENIX trial

Region

Japan


Condition

Condition

gastric cancer with peritoneal metastasis or positive peritoneal cytology

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of S-1 plus intravenous and intraperitoneal paclitaxel in gastric cancer patients with peritoneal metastasis or positive peritoneal cytology

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

safety

Key secondary outcomes

overall survival
response rate
negative conversion rate on peritoneal cytology


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

intraperitoneal PTX 20 mg/m2, intravenous PTX 50 mg/m2 on days 1 and 8, S-1 80 mg/m2/day on days 1-14, q3 weeks

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


Not applicable

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

1) Pathologically proven primary gastric adenocarcinoma
2) Peritoneal metastasis or positive peritoneal cytology
3) Adequate function of important organs (within 14 days before registration)
NEU >=1,000/mm3
Hemoglobin >=8.0g/dL
Platelet >=75,000/mm3
AST <=150U/L, ALT <=150U/L
T-Bilirubin <=3.0mg/dL
Creatinine clearance >=30mL/min
4) Eastern Cooperative Oncology Group performance status 0-2
5) Age >= 20, < 75 years
6) Written informed consent

Key exclusion criteria

1) Distal metastasis other than to the peritoneum, ovary and abdominal lymph nodes
2) Contraindication to S-1 or paclitaxel
3) Apparent infection or inflammation
4) Severe heart disease
5) Severe complication
6) Gastrointestinal tract bleeding requiring blood transfusion
7) Pregnancy, breast feeding or intention to become pregnant
8) Judged inappropriate for this trial for other reasons

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironori Ishigami

Organization

The University of Tokyo Hospital

Division name

Department of Chemotherapy

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

ishigami-tky@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Hironori Ishigami

Organization

The University of Tokyo Hospital

Division name

Department of Chemotherapy

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

ishigami-tky@umin.net


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

The University of Tokyo

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

2016 Year 10 Month 01 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

2016 Year 09 Month 21 Day

Date of IRB

2016 Year 10 Month 13 Day

Anticipated trial start date

2016 Year 10 Month 14 Day

Last follow-up date

2023 Year 08 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 14 Day

Last modified on

2024 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027201


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name