UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013491 |
|---|---|
| Receipt number | 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 23:28:17 |
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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
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
hfunaki@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology, Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015757
