Unique ID issued by UMIN | UMIN000006378 |
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Receipt number | R000007525 |
Scientific Title | Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial |
Date of disclosure of the study information | 2011/09/21 |
Last modified on | 2019/01/24 15:30:26 |
Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial
COMPASS-D trial
Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial
COMPASS-D trial
Japan |
gastric cancer
Gastrointestinal surgery |
Malignancy
NO
he present study aims to evaluate effficacy and safety of neoadjuvant chemotherapy among 2 and 4 courses of S-1/CDDP and S-1/CDDP/Docetaxel followed by curative surgery and adjuvant chemotherapy with S-1 in locally advanced gastric cancer patients who have poor prognosis without neoadjuvant chemotherapy.
Safety,Efficacy
Phase II
Three-year overall survival rate
overall survival,
progression-free survival, pathological response,
clinical response,
R0 resection rate,
R0R1 resection rate,
completion rate of neoadjuvant chemotherapy, incidence of adverse events, and these parameters in each subset
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
4
Treatment
Medicine |
2 courses of S-1/CDDP
4 courses of S-1/CDDP
2 courses of S-1/CDDP/Docetaxel
4 courses of S-1/CDDP/Docetaxel
20 | years-old | <= |
80 | years-old | >= |
Male and Female
i. Histologically proven adenocarcinoma of the stomach
ii. Clinical T4, or T3 disease in cases of tumors invading the esophagus or of the schirrhous type including giant type 3 with a maximal diameter of more than 8 cm, confirmed by abdominal CT and laparoscopy. The T and N stages are determined according to the method proposed by Haberrmann.
iii. No pleural effusion, no ascites exceeding pelvis, and no metastasis to the peritoneum, liver, or other distant organs, confirmed by abdominal-pelvic CT.
iv. No metastasis to the lung, mediastinal lymph nodes, or the other distant organs, confirmed by thoracic CT for tumors invading the esophagus.
v. No clinically apparent distant metastasis
vi. Age ranging between 20 and 80.
vii. ECOG performance status 0-1
viii. Enough oral intake
ix. No previous treatment with chemotherapy or radiation therapy for any tumors
x. No previous surgery for the present disease except bypass surgery
xi. Sufficient organ functions
xii. Written informed consent.
i. Remnant stomach cancer
ii. Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included).
iii. Females with an on-going pregnancy or breast-feeding, or who are contemplating pregnancy.
iv. Mental disorders which may affect the ability or willingness to provide informed consent or abide by the study protocol
v. Systemic treatment with a corticosteroid
vi. Systemic treatment with flucytosine, phenytoin, or warfarin potassium
vii. Allergic reaction to iodine
viii. Hypersensitivity to docetaxel, cisplatin, or polysorbate 80
ix. Peripheral neuropathy
x. Edema
xi. Pneumonitis, lung fibrosis, or emphysema in need for oxygen therapy
xii. Active inflammation due to bacteria or fungus
xiii. Unstable angina or cardiac infarction within 6 months
xiv. Positive for HBs antigen or HCV antibody
xv. Unstable hypertension
xvi. Diabetes mellitus under treatment.
120
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
yoshikawat@kcch.jp
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
yoshikawat@kcch.jp
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)
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)
昭和大学藤が丘病院(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)
大阪府立急性期・総合医療センター(大阪府)
広島市立安佐市民病院(広島県)
NTT西日本大阪病院(大阪府)
広島大学病院(広島県)
愛知県がんセンター愛知病院(愛知県)
神戸市立医療センター中央市民病院(兵庫県)
市立堺病院(大阪府)
国立病院機構大阪医療センター(大阪府)
2011 | Year | 09 | Month | 21 | Day |
Published
Gastrointestinal Cancer Symposium 2019
(ASCO-GI 2019)
2019/1/17
Considering high 3-year OS, four courses DCS has a value to be tested in a future phase III study to confirm superiority of neoadjuvant chemotherapy for locally advanced gastric cancer.
Completed
2011 | Year | 09 | Month | 12 | Day |
2011 | Year | 09 | Month | 12 | Day |
2016 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 21 | Day |
2019 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007525
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