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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005907
Receipt No. R000006986
Scientific Title A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)
Date of disclosure of the study information 2011/07/08
Last modified on 2018/07/06

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Basic information
Public title A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)
Acronym A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)
Scientific Title A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)
Scientific Title:Acronym A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)
Region
Japan

Condition
Condition cT3(SS) or cT4 (SE/SI) gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of extensive intraoperative peritoneal lavage for cT3(SS) or cT4(SE/SI) gastric cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Disease-free survival
Key secondary outcomes Overall survival, peritoneal recurrence-free survival, surgical complications

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A: standard lavage
Interventions/Control_2 B: extensive lavage
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1st inclusion criteria (before surgery)
1) Histologically proven primary gastric adenocarcinoma
2) cT3(SS)-T4b(SI)
3) cH0 and M0
4) Scheduled open surgery
5) Possible for R0 or R1 surgery by distal or total gastrectomy with D2 lymphadenectomy
5) Length of esophageal invasion less or equal to 3cm and no need of thoracotomy for resection
7) Not stump cancer of stomach
8) Age 20 to 80 years old
9) PS(ECOG) of 0 or 1
10) Adequate organ functions for gastrectomy
11) Written informed consent from patient

2nd inclusion criteria (during surgery)
1) cT3(SS) - cT4b(SI)
2) cH0 M0
3) No peritoneal dissemination or a few peritoneal dissemination around stomach
4) Possible for R0 or R1 surgery due to only CY1
5) No need of thoracotomy for resection
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Uncontrollable hypertension or uncontrollable diabetes mellitus
3) Continuous systemic steroid therapy
4) Judged by physician inadequate for inclusion in this trial
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Misawa
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL 0527626111
Email misawakzn@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunari Misawa
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL 0527626111
Homepage URL
Email misawakzn@aichi-cc.jp

Sponsor
Institute Chubu Clinical Oncology Group (CCOG)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Chubu Clinical Oncology Group (CCOG)
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 名古屋大学(愛知県)
愛知県がんセンター愛知病院(愛知県)
愛知県がんセンター中央病院(愛知県)
渥美病院(愛知県)
一宮市立市民病院(愛知県)
岡崎市民病院(愛知県)
海南病院(愛知県)
江南厚生病院(愛知県)
小牧市民病院(愛知県)
県立多治見病院(愛知県)
中日病院(愛知県)
東海中央病院(愛知県)
公立陶生病院(愛知県)
豊橋医療センター(愛知県)
中津川市民病院(愛知県)
名古屋医療センター(愛知県)
名古屋記念病院(愛知県)
名古屋セントラル病院(愛知県)
名鉄病院(愛知県)
市立四日市病院(三重県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2011 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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
2011 Year 07 Month 01 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006986


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