Unique ID issued by UMIN | UMIN000011662 |
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Receipt number | R000011564 |
Scientific Title | Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma |
Date of disclosure of the study information | 2013/09/05 |
Last modified on | 2013/09/05 20:38:51 |
Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma
Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma
Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma
Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma
Japan |
Advanced lung squamous cell carcinoma
Pneumology |
Malignancy
NO
To determine the optimal administration method of Maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1, and to investigate the efficacy and safety of the method in advanced lung squamous cell
Safety,Efficacy
Phase II
Progression free survival (PFS)
Overall survival (OS), Response rate (RR) and Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration method 1:first dose CBDCA :AUC5(day1)+ S-1:80mg/m2(day1-14)
q3weeks
Administration method 2:Platelet < 75,000/mm3 or grade 3 adverse event at Administration method 1
CBDCA :AUC5(day1)+
S-1:80mg/m2(day1-14)
q4weeks
Administration method 3:Platelet < 75,000/mm3 or grade 3 adverse event at administration method 2, or on and after 7th course
S-1:80mg/m2(day1-14)
q3weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Patients with histlogically or cytologically confirmed lung squamous cell carcinoma
2)Patients with clinical stage of IIIB-IV or recurrence after operation
3) 20<=, <75 years old
4)ECOG Performance status 0-1
5) Expected survival more than 3 months
6)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors
7) With ability of oral intake
8)No prior chemotherapy nor radiation therapy
9)Adequate bone marrow reserve and organ function
10)Written IC
1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray
2)Patients with pleural or pericardial effusion ,or ascites
3) Patients with active double cancer
4)Patients with significant complications
a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months
b)Uncontrolled diabetes or hypertension
c)Current severe infection, or suspicious of severe infection
d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella)
5)Patients with symptomatic brain metastasis
6)Patients with pregnancy or lactation
7) History of serious drug allergy
8) History of serious allergic reaction with CBDCA or other platinum-containing drug
9) History of serious allergic reaction with S-1
10) Being treated with other pyrimidine fluoride antineoplastic agents.
11) Being treated with flucytosine.
12) Any patients judged by the investigator to be unfit to participate in the study
37
1st name | |
Middle name | |
Last name | Yoshiki Ishii |
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
ishiiysk@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Yoshiki Ishii |
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
ishiiysk@dokkyomed.ac.jp
Dokkyo Medical University
Dokkyo Medical University
Self funding
NO
2013 | Year | 09 | Month | 05 | Day |
Unpublished
Open public recruiting
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 05 | Day |
2013 | Year | 09 | Month | 05 | Day |
2013 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011564
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