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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003201
Receipt No. 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

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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
Institute Study group of multi-modality therapy for gastric cancer
Institute
Department

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
URL(English) https://upload.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


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