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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013491
Receipt No. R000015757
Scientific Title Prospective Cohort Study Evaluating the Prognosis of Patients with Resectable Large 3 and 4 Type Gastric Cancer and Clinical Phase II trial Evaluating the Safety and Benefit of Perioperative Chemotherapy for Resectable Large 3 and 4 Type Gastric Cancer
Date of disclosure of the study information 2014/03/24
Last modified on 2014/03/23

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Basic information
Public title Prospective Cohort Study Evaluating the Prognosis of Patients with Resectable Large 3 and 4 Type Gastric Cancer and
Clinical Phase II trial Evaluating the Safety and Benefit of Perioperative Chemotherapy for Resectable Large 3 and 4 Type Gastric Cancer
Acronym CoBLa trial
Scientific Title Prospective Cohort Study Evaluating the Prognosis of Patients with Resectable Large 3 and 4 Type Gastric Cancer and
Clinical Phase II trial Evaluating the Safety and Benefit of Perioperative Chemotherapy for Resectable Large 3 and 4 Type Gastric Cancer
Scientific Title:Acronym CoBLa trial
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the prognosis of patients with resectable large 3 and 4 type gastric cancer and evaluating the safety and efficacy of perioperative chemotherapy for these patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes The proportion of the patients who completed the treatment
Key secondary outcomes The proportion of adverse events, DFS, and OS.

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 Perioperative chemotherapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cohort study
1. pathologically confirmed gastric cancer in biopsy specimens.
2. macrosopic type 3 or 4
3. 8cm and more in case of macrosopic type 3
4. clinical M0, P0, H0, N0-2
5. without any prior therapy
2) Phase II trial
Enrolled in cohort study and satisfy the following conditions.
1. esophageal invasion length is 3cm or less
2. diagnostic laparoscopy(option) shows POCY0 or POCY1.
3. age: 20 and more
4. PS(ECOG): 0-2
5. patients who can take medicine orally
6. with adequate major organ functions within 14 days before trial entry.
7. written informed consents
Key exclusion criteria 1. administration contraindication of TS-1, CDDP, DOC, PAC
2. severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure etc.
3. massive ascites or pleural effusion
4. severe watery diarrhea
5. schronous double cancer
6. pregnancy or lactation
7. physician concludes that the patient's participation in this trial is inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Koska
Organization Kanazawa Medical University
Division name Department of Surgical Oncology
Zip code
Address 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa
TEL 076-286-2211
Email tkosaka@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Funaki
Organization Kanazawa Medical University
Division name Department of Surgical Oncology
Zip code
Address 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa
TEL 076-286-2211
Homepage URL
Email hfunaki@kanazawa-med.ac.jp

Sponsor
Institute Department of Surgical Oncology, Kanazawa Medical University
Institute
Department

Funding Source
Organization none
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
2014 Year 03 Month 24 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 23 Day
Last modified on
2014 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015757

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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