UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022321 |
|---|---|
| Receipt number | R000025719 |
| Scientific Title | International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1 |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2018/11/26 14:25:26 |
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Basic information
Public title
International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1
Acronym
International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1 (CONVO-GC-1)
Scientific Title
International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1
Scientific Title:Acronym
International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1 (CONVO-GC-1)
Region
| Japan | Asia(except Japan) |
Condition
Condition
StageIV gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to clarify the present information of conversion therapy of stage IV gastric cancer in Asian counties, to investigate the feasibility of the therapy and to collect the baseline data for future analysis to clarify the role of the therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of operative complications after conversion therapy
Key secondary outcomes
Overall Survival(OS), Relapse free survival(RFS), Response rate, and Histological response
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To clarify the meaning of conversion therapy, we need to collect all stage IV gastric cancer patients who underwent operation with successful chemoradiationtherapy.
1. Histologically proven primary gastric adenocarcinoma.
2. Stage IV gastric cancer patients initially regarded as non-curably resectable but with successful chemotherapy, regarded as curably resectable (R0), then underwent radical operation (including metastasectomy).
3. Stage IV gastric cancer patients initially regarded as resectable, underwent radical operation after chemotherapy (neoadjuvant case).
4. Stage IV gastric cancer patients with peritoneal dissemination or positive cytology by staging laparoscopy or laparotomy but with successful chemotherapy, then underwent radical operation, or patients who underwent gastrectomy irrespective of chemotherapy.
Key exclusion criteria
None
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro YOSHIDA |
Organization
Gifu University School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
Yanagido 1-1, Gifu-city, Gifu
TEL
058-230-6235
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami SAKURAI |
Organization
Federation of Asian Clinical Oncology (FACO)
Division name
Tokyo Office
Zip code
Address
Shinkawa Bldg. 2F, 2-13-10, Shinkawa, Chu-ku, Tokyo 104-0033 Japan
TEL
03-5542-0546
Homepage URL
faco-office@jsco.or.jp
Sponsor or person
Institute
FACO(Federation of Asian Clinical Oncology)
Institute
Department
Personal name
Funding Source
Organization
FACO(Federation of Asian Clinical Oncology)
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
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
| 2016 | Year | 05 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
Questionnaire survey (Retrospective cohort study) for patients completed adjuvant surgery from 01Jan2001 to 31Dec2014.
Surveillance items of clinical data
I. Sequence of diagnosis and treatment
II. Patients' background information at diagnosis, Tumor status: Pathological diagnosis, Lauren classification, Depth of tumor, Lymph node metastasis, Liver metastasis, Peritoneal dissemination, Tumor diameter, Location of metastasis, Diagnostic staging laparoscopy, Diagnostic method for peritoneal dissemination, Other cancers, Complication and comorbidity, Having target lesion or not, HER2 status.
III. Treatment status of chemotherapy and radiation therapy: Regimen, number of cycle, the reason of discontinuation, Dose and period of radiation therapy.
IV. Evaluation of Response: Overall response evaluated by RECIST version 1.1.
V. Surgical and Pathological Information: Type of tumor, Histological type, tumor diameter, Lymph node metastasis, number of metastasis and dissected lymph node, distant metastasis, Liver metastasis, Peritoneal dissemination, Peritoneal lavage cytology, Proximal and distal margin, Residual tumor, Reason for conversion therapy, Date of surgery, Operation time, Estimated blood loss, Volume of blood transfusion, mode of operation, Extension of lymph node dissection, Combined organ resection, Histological response.
VI. Postoperative Complications: Wound infection, Thromboembolism, Anastomotic leakage, Intraperitoneal abscess, Pancraticfistula, Postoperative pneumonia, others.
VII. Postoperative treatment status: Regimen of chemotherapy, number of cycle, Reason of discontinuation, dose and period of radiation therapy, Reason of no treatment.
VIII. Confirmation of outcome: Date last known to be alive or date of death, Cause of death, Date of tumor relapse after curative resection, recurrent site, Survival status, Method of confirmation of outcome, Tumor relapse/recurrence.
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025719
