UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004960 |
|---|---|
| Receipt number | R000005879 |
| Scientific Title | Feasibility trial of neoadjuvant chemoradiotherapy in patients with locally advanced gastric cancer |
| Date of disclosure of the study information | 2011/01/26 |
| Last modified on | 2011/03/04 15:11:15 |
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Basic information
Public title
Feasibility trial of neoadjuvant chemoradiotherapy in patients with locally advanced gastric cancer
Acronym
Feasibility trial of neoadjuvant chemoradiotherapy in patients with locally advanced gastric cancer
Scientific Title
Feasibility trial of neoadjuvant chemoradiotherapy in patients with locally advanced gastric cancer
Scientific Title:Acronym
Feasibility trial of neoadjuvant chemoradiotherapy in patients with locally advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in patients with locally far-advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feasibility
safety
Key secondary outcomes
pathological response rate
overall survival.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) histologically proven gastric adenocarcinoma
2) tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
3) no metastases outside of Group 2 lymph nodes, no peritoneal metastasis, no liver metastasis and no other distant metastasis
4) PS0 - PS2
5) no prior radiation therapy
6) sufficient organ function
7) written informed consent
Key exclusion criteria
1) a synchronous or previously active malignancy
2) insufficient oral intake
3) a history of severe allergy
4) watery diarrhea
5) severe co-morbidities
6) requiring therapy for pericardial effusion or pleural effusion
7) contraindications to S-1 or radiotherapy
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Suzuki |
Organization
School of Medicine, Kagawa University
Division name
Department of Gastroenterological
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2438
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsushi Inoue |
Organization
Surgery, School of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2111
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological Surgery, School of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
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
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
香川大学病院(香川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 26 | 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
| 2005 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
The present study design: a Monocenter prospective, Non-randomized observational study.
Feasibility, safty, pathological response and over all survival will be investigated.
Management information
Registered date
| 2011 | Year | 01 | Month | 26 | Day |
Last modified on
| 2011 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005879
