Unique ID issued by UMIN | UMIN000007941 |
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Receipt number | R000009278 |
Scientific Title | Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion (HERBIS-1B) (OGSG 1202) |
Date of disclosure of the study information | 2012/05/14 |
Last modified on | 2020/01/22 22:19:14 |
Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion
(HERBIS-1B) (OGSG 1202)
HER2-Based Strategy in Gastric Cancer (HERBIS-1B) (OGSG 1202)
Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion
(HERBIS-1B) (OGSG 1202)
HER2-Based Strategy in Gastric Cancer (HERBIS-1B) (OGSG 1202)
Japan |
Advanced Gastric Cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and efficacy of TS-1+cisplatin+Trastuzumab 3-weekly schedule regimen for initially unresectable advanced gastric cancer without measurable lesion
Safety,Efficacy
Exploratory
Explanatory
Phase II
Overall Survival(OS)
Safety
Progression-free survival (PFS)
Time to treatment failure (TTF)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Drug: TS-1, cisplatin, and trastuzumab
TS-1: 80 mg/m2/day po on Days 1-14
Cisplatin: 60 mg/m2 iv on Day 1
Trastuzumab: 8 mg/kg iv on Day 1 (first course), and 6 mg/kg iv on Day 1 (from second courses)
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
2. Patients who have no measurable legion defined by RECIST version 1.1 within 21 days before enrollment
3. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive)
4. Age 20-75
5. Performance status (ECOG scale) 0 or 1
6. No prior chemotherapy or radiotherapy for gastric cancer
7. No massive ascites or massive pleural effusion retention
8. Patients without brain metastasis
9. Adequate baseline organ and marrow function as defined below;
a) Leukocytes: >=3,500 /mm3 <=12,000 /mm3
b) Absolute neutrophil count: >=2,000 / mm3
c) Platelets: >=100,000 / mm3
d) Hemoglobin: >=9.0 g/dL
e) AST (SGOT)/ALT (SGPT) < 100 IU/L
f) Total bilirubin <1.5 mg/dL
g) Serum creatine >=1.2 mg/dL
h) Creatinine clearance: >=60 mL/min
i) Patients with left ventricular ejection fraction of at least 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography done within 21 days before enrollment.
11. No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment
12. Patients able to take orally.
13. Life expectancy of greater than 3 months.
14. Patients should sign a written informed consent
1. Patients who are contraindicated to S-1, CDDP, and Trastuzumab
2. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant
3. Patient with active infection
4. Patients have Active hepatitis type B.
5. Serious illness or medical conditions as defined below,
a) Patient with a previous history of congestive heart failure
b) Hi-risk uncontrolled arrhythmias
c) Unstable angina requiring medication
d) Patient with a previous history of myocardial infarction
e) Severe heart valve disease
f) Patient with a previous history of transmural infarct
g) Uncontrolled hypertension
6. Serious complication as followings,
a) Interstitial pneumonia
b) Pulmonary fibrosis
c) Heart failure
d) Renal failure
e) Hepatic failure
f) Uncontrolled diabetes mellitus
7. Patients with resting dyspnea
8. Patients with fresh bleeding from gastric cancer and/or the digestive tract
9. Patients with diarrhea (4 or more times per day or watery diarrhea).
10. Second primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence)
11. Patients who are received systemic continuous administration of flucytosine, phenytoin or warfarin
12. Patients who are received systemic administration of corticosteroid
13. Any patients judged by the investigator to be unfit to participate in the study
40
1st name | |
Middle name | |
Last name | Yukinori Kurokawa |
Osaka University Graduate School of Medicine
Department of Gastroenterological Surgery
2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
06-6879-3251
ykurokawa@gesurg.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yukinori Kurokawa |
Osaka University Graduate School of Medicine
Department of Gastroenterological Surgery
2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
06-6879-3251
ykurokawa@gesurg.med.osaka-u.ac.jp
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Osaka Clinical Study Supporting Organization
Other
Japan
NO
東大阪市立総合病院(大阪府)、大崎市民病院(宮城県)、箕面市立病院(大阪府)、堺市立総合医療センター(大阪府)、大阪大学(大阪府)、八尾市立病院(大阪府)、昭和大学横浜市北部病院(神奈川県)、大阪警察病院(大阪府)、大阪医療センター(大阪府)、関西労災病院(兵庫県)
2012 | Year | 05 | Month | 14 | Day |
http://ar.iiarjournals.org/content/39/2/1059
Published
http://ar.iiarjournals.org/content/39/2/1059
15
Fifteen patients were enrolled. The median overall survival was 14.4 months. The 1- and 3-year overall survival rates were 66.7 % and 26.7 %, respectively.
2020 | Year | 01 | Month | 05 | Day |
2019 | Year | 01 | Month | 15 | Day |
Patients with HER2-positive gastric cancer without measurable lesions
Patients with HER2-positive gastric cancer without measurable lesions received cisplatin plus trastuzumab intravenously on day 1 and oral S-1 on days 1-14 of a 21-day cycle.
Major grade 3-4 adverse events included neutropenia (47%), anemia (40%), diarrhea (20%), nausea (20%), and anorexia (20%).
The primary end-point was overall survival.
Completed
2012 | Year | 04 | Month | 23 | Day |
2012 | Year | 07 | Month | 24 | Day |
2013 | Year | 02 | Month | 22 | Day |
2018 | Year | 03 | Month | 16 | Day |
2018 | Year | 05 | Month | 28 | Day |
2012 | Year | 05 | Month | 13 | Day |
2020 | Year | 01 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009278
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