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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006379
Receipt No. R000007534
Scientific Title Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy of docetaxel / S-1 / cisplatin or S-1 / cisplatin for operable gastric cancer, a randomized phase II trial
Date of disclosure of the study information 2011/09/21
Last modified on 2013/10/29

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Basic information
Public title Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy of docetaxel / S-1 / cisplatin or S-1 / cisplatin for operable gastric cancer, a randomized phase II trial
Acronym LANDSCOPE trial
Scientific Title Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy of docetaxel / S-1 / cisplatin or S-1 / cisplatin for operable gastric cancer, a randomized phase II trial
Scientific Title:Acronym LANDSCOPE trial
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to evaluate the safety and efficacy of LADG compared with ODG for gastric cancer which is macroscopically resectable by D2 gastrectomy, to determine whether LADG can be a test arm for a future phase III trial to evaluate the non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Three-year overall survival rate
Treatment-related death
Key secondary outcomes overall survival
overall survival after 1st endollment
surgical morbidity and mortality,
R0 resection rate,
R0R1 resection rate,
conversion rate,
efficacy and safety in patients who complete the surgery
efficacy and safety in each subset.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Open distal gastrectomy with D2 lymph node dissection
Interventions/Control_2 Laparoscopic distal gastrectomy with D2 lymph node dissection
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1st enrollment
i. Histologically proven adenocarcinoma of the stomach
ii.Clinical T4aN0-N3 disease, confirmed by upper gastrointestinal endoscopy or an upper gastrointestinal series, and abdominal CT and laparoscopy.
iii.The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
iv.No bulky lymph node metastasis is detected by abdominal CT
v.No metastasis to the lung, mediastinal lymph nodes, or the other distant organs, confirmed by thoracic CT for tumors invading the esophagus.
vi.No clinically apparent distant metastasis
vii.Age ranging between 20 and 80.
viii.ECOG performance status 0-1
ix.Enough oral intake
x.No previous treatment with chemotherapy or radiation therapy for any tumors
xi.No previous surgery for the present disease except bypass surgery
xii.The patients were enrolled in the COMPASS-D phase 2 trial comparing neoadjuvant chemotherapy with 2 and 4 courses of S-1 plus cisplatin (SC) or S-1 plus cisplatin and docetaxel (SCD) by a two by a two factorial design for patients with macroscopically resectable serosa-positive gastric cancer, and receive neoadjuvant chemotherapy.
xiii.Written informed consent.

2nd enrollment
i.Patients received 2 or 4 courses of SC or SCD defined by the COMPASS-D trial.
ii.The gastric tumors are macroscopically resectable disease by distal gastrectomy with D2 lymph node dissection. Resectability are evaluated by upper gastrointestinal endoscopy and CT 7 to 21 days after the date when the anti-cancer drugs were given.
iii.No T4b disease
iv.No bulky lymph node metastasis
v.Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anti-cancer drugs were given.
vi.No need for emergency surgery due to bleeding or perforation of the primary tumor
vii.No need for emergency surgery due to stenosis
viii.No mechanical obstruction
Key exclusion criteria i.Past history of upper-abdominal surgery
ii.Past history of surgery for the gastrointestinal tract
iii.Body mass index exceeding 30 kg/m2.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaki Yoshikawa
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815
TEL 045-391-5761
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takaki Yoshikawa
Organization Yokohama City University Medical Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 1-1-2 Nakao, Asahi-ku, Yokohama City, 241-0815, Japan
TEL 045-391-5761
Homepage URL
Email

Sponsor
Institute non-profit organization KSATTS
Institute
Department

Funding Source
Organization non-profit organization KSATTS
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 神奈川県立がんセンター(神奈川県)
横浜市立大学附属病院市民総合医療センター(神奈川県)
聖マリアンナ医科大学(神奈川県)
北里大学東病院(神奈川県)
札幌厚生病院(北海道)
獨協医科大学越谷病院(埼玉県)
昭和大学藤が丘病院(神奈川県)
済生会横浜市東部病院(神奈川県)
愛知県がんセンター中央病院(愛知県)
福井県済生会病院(福井県)
徳島大学病院(徳島県)
独立行政法人国立病院機構 相模原病院(神奈川県)
大阪府立急性期・総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 21 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 Terminated
Date of protocol fixation
2011 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 09 Month 21 Day
Last modified on
2013 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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