Unique ID issued by UMIN | UMIN000006379 |
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Receipt number | 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 09:55:45 |
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
LANDSCOPE trial
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
LANDSCOPE trial
Japan |
gastric cancer
Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Phase II
Three-year overall survival rate
Treatment-related death
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Open distal gastrectomy with D2 lymph node dissection
Laparoscopic distal gastrectomy with D2 lymph node dissection
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
i.Past history of upper-abdominal surgery
ii.Past history of surgery for the gastrointestinal tract
iii.Body mass index exceeding 30 kg/m2.
80
1st name | |
Middle name | |
Last name | Takaki Yoshikawa |
Kanagawa Cancer Center
Department of Gastrointestinal Surgery
1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815
045-391-5761
1st name | |
Middle name | |
Last name | Takaki Yoshikawa |
Yokohama City University Medical Center
Department of Gastrointestinal Surgery
1-1-2 Nakao, Asahi-ku, Yokohama City, 241-0815, Japan
045-391-5761
non-profit organization KSATTS
non-profit organization KSATTS
Self funding
Japan
NO
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)
2011 | Year | 09 | Month | 21 | Day |
Unpublished
Terminated
2011 | Year | 09 | Month | 12 | Day |
2011 | Year | 09 | Month | 01 | Day |
2019 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 21 | Day |
2013 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007534
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