A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
- Conditions
- gastric cancer
- Registration Number
- JPRN-jRCTs071180066
- Lead Sponsor
- Suyama Koichi
- Brief Summary
The one-year survival rate (primary endpoint) was more than 60%. The median overall survival (16.4 months), median progression-free survival (5.8 months), and response rate (60.9%), which are secondary endpoints, also showed the efficacy of this therapy. The safety was also acceptable. S-1 + ramucirumab therapy showed a good antitumor response and acceptable toxicity in advanced or recurrent gastric cancer over 70 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
1) Individuals who have consented in writing.
2) A lead investigator deems that the patient can be treated with the protocol.
3) Patients with gastric cancer that is not amenable to curative surgery or that is recurrent and that has been histopathologically confirmed to be primary adenocarcinoma of the stomach or gastroesophageal junction.
4) Patients with cancer that is HER2-negative (HER2-indeterminate are eligible).
5) Patients who are able to take medication orally.
6) Patients who are age 70 or older when they provide consent.
7) Patients with an ECOG Performance status of 0-1.
8) Criteria prior to treatment
i.Patients who have not previously undergone surgery.
ii.Patients who have previously undergone surgery
A)Patients who underwent a curative resection.
B)Patients who underwent non-curative surgery.
C)Exploratory laparotomy, bypass surgery, etc.
9) The patient has no severe dysfunction of major organs (bone marrow,liver,kidneys,heart,lungs,etc.) and the patient's laboratory results from up to 14 days prior to enrollment meet the following criteria:
i. Neutrophil count>=1,500/mm^3
ii. Platelet count>=100,000/mm^3
iii. Hemoglobin>=9.0 g/dL
iv. Total bilirubin=<1.5 mg/dL
v. AST=<3xULN (A level of =<5xULN is permitted for patients with liver metastasis)
vi. ALT=<3xULN (A level of 5xULN is permitted for patients with liver metastasis)
vii. Albumin>=2.5 g/dL
viii. Dipstick urinalysis results in a reading=<1+ protein.
ix. Creatinine clearance>=40 mL/min
x. Clotting: Patients with appropriate clotting as defined by an international normalized ratio (INR) of 1.5 or less and a partial thromboplastin time (PTT) no more than 5 seconds above the ULN (when not receiving anticoagulant therapy).
1)Patients who have severe drug hypersensitivity.
2)Patients who have undergone major surgery up to 28 days prior to enrollment or in whom a central venous access device has been placed up to 7 days prior to the initial treatment. Patients who are scheduled to undergo major surgery during the study period. Patients with a severe hemorrhagic disorder within 12 weeks of enrollment.
3)Patients who have had a gastrointestinal perforation and/or fistula up to 6 months prior to enrollment.
4)Patients with a serious or non-healing wound up to 28 days prior to enrollment.
5)Patients who have had deep vein thrombosis, pulmonary embolism, or some other major form of thromboembolism up to 3 months prior to enrollment.
6)The patient has experienced any arterial thromboembolic events, within 6 months prior to first protocol therapy.
7)Patients receiving chronic administration of a non-steroidal antiinflammatory drug or some other antiplatelet drug.
8)Patients with an active infection.
9)Patients with hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) that cannot be adequately controlled with 2 antihypertensives.
10)Patients with diabetes mellitus that cannot be controlled adequately with medication.
11)Patients with heart disease that may pose a problem.
12)Patients with severe pulmonary disease.
13)Patients with a psychiatric disorder.
14)Patients with active gastrointestinal tract bleeding requiring repeated transfusions.
15)Patients receiving phenytoin, warfarin potassium, or flucytosine.
16)Patients with diarrhea (Grade 2 or worse).
17)Patients with active multiple cancers.
18)Men who wish to conceive with a partner.
19)Patients with hepatic cirrhosis or active hepatitis.
20)Patients with cirrhosis, with a history of hepatic encephalopathy, or with clinically significant ascites.
21)Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year survival rate
- Secondary Outcome Measures
Name Time Method Overall survival (OS)<br>Progression-free survival (PFS)<br>Response rate (RR)<br>safety (Safety)