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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name