UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003201
Receipt number R000003870
Scientific Title A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma
Date of disclosure of the study information 2010/02/17
Last modified on 2019/09/04 15:15:45

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Basic information

Public title

A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma

Acronym

chemoradiation therapy for advanced or recurrent gastric adenocarcinoma

Scientific Title

A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma

Scientific Title:Acronym

chemoradiation therapy for advanced or recurrent gastric adenocarcinoma

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy of chemoradiation therapy with paclitaxel and cisplatin for local symptoms
due to an unresectable primary advanced or locally
recurrent gastric adenocarcinoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Improvement of gastrointestinal obstruction and/or localized pain

Key secondary outcomes

Improved duration of gastrointestinal obstruction , survival time, adverse event


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

chemoradiation therapy
with paclitaxel and cisplatin

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed gastric cancer
2) Patients who have local symptoms
due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma
3) Age between 20 to 80 at registration
4) ECOG PS 0 to 1
5) No or one history of chemotherapy for gastric cancer(adjuvant chemotherapy is excluded)
6) No history of chemotherapy with paclitaxel and cisplatin or chemotherapy including cisplatin(over 240mg/m2)
7) 3 weeks after other chemotherapy
8) No history of radiation therapy for left upper abdomen
9) Over 2 months survival is expected
10) adequate organ function
11) No other active malignancy
12) Written informed consent

Key exclusion criteria

1) Tumor localization is not detected by neither CT, endoscopy nor upper GI series
2) Serious comorbidities
3) Severe GI obstruction or gastrointestinal bleeding
4) Current inflammation or acute inflammatory disease
5) Allergy to cremophor EL
6) Brain metastasis with symptom
7) Female with present pregnancy or breast-feeding, or contemplating pregnancy.
8) Registered to other clinical trial
9) Patients judged inappropriate for the study by the physicians

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takaki
Middle name
Last name Yoshikawa

Organization

Kanagawa Cancer Center

Division name

Department of Gastrointestinal Surgery

Zip code

241-8515

Address

1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan

TEL

0455202222

Email

takay0218@yahoo.co.jp


Public contact

Name of contact person

1st name Takanobu
Middle name
Last name Yamada

Organization

Kanagawa Cancer Center

Division name

Department of Gastrointesitnal Surgery

Zip code

241-8515

Address

1-1-2 Nakao Asahi-Ku, Yokohama 241-0815, Japan

TEL

0455202222

Homepage URL


Email

takay0218@yahoo.co.jp


Sponsor or person

Institute

Study group of multi-modality therapy for gastric cancer

Institute

Department

Personal name



Funding Source

Organization

Kanagawa standard anti-cancer therapy support system (KSATSS)

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

Kanagawa Cancer Center

Address

2-3-2 Nakao Asahi Yokohama Kanagawa Japan

Tel

0455202222

Email

takay0218@yahoo.co.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

2010 Year 02 Month 17 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

5

Results

This trial was terminated, because sufficient number of patients enrolled.

Results date posted

2019 Year 09 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Impossible to evaluate

Participant flow

Impossible to evaluate

Adverse events

Impossible to evaluate

Outcome measures

Impossible to evaluate

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2008 Year 03 Month 12 Day

Date of IRB

2019 Year 02 Month 22 Day

Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry

2017 Year 09 Month 30 Day

Date trial data considered complete

2017 Year 09 Month 30 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 02 Month 17 Day

Last modified on

2019 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003870


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name