UMIN-CTR Clinical Trial

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

cT3(SS) or cT4 (SE/SI) gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Disease-free survival

Key secondary outcomes

Overall survival, peritoneal recurrence-free survival, surgical complications

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chubu Clinical Oncology Group (CCOG)

Institute

Department

Personal name

Organization

Chubu Clinical Oncology Group (CCOG)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

07

Month

08

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2011

Year

07

Month

01

Day

Last modified on

2018

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006986