Unique ID issued by UMIN | UMIN000007049 |
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Receipt number | R000008140 |
Scientific Title | Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer |
Date of disclosure of the study information | 2012/01/18 |
Last modified on | 2019/04/20 14:14:09 |
Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)
Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)
Japan |
Advanced non-small-cell lung cancer in elderly patients
Pneumology |
Malignancy
NO
To determine the recommend dose of TS-1 plus CBDCA chemotherapy, and to investigate the efficacy and safety of the recommend dose in elderly patients with advanced non-small-cell lung cancer
Safety,Efficacy
Phase I,II
Phase I study: MTD, RD
Phase II study : Response rate in RD
Phase I study: Safety
Phase II study : OS, PFS and Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Level0
CBDCA :AUC4(day1)+
S-1:65mg/m2(day1-14)
q3weeks
Level1
CBDCA :AUC4(day1)+
S-1:80mg/m2(day1-14)
q3weeks
Level2
CBDCA :AUC5(day1)+
S-1:80mg/m2(day1-14)
q3weeks
75 | years-old | <= |
Not applicable |
Male and Female
1)Patients with histlogically or
cytologically confirmed non-small cell lung cancer
2)Patients with clinical stage of IIIB-IV or recurrence after operation
3)Elderly patients over 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
35
1st name | |
Middle name | |
Last name | Takashi KASAI |
Tochigi Cancer Center
Division of Thoracic Oncology
4-9-13 Yonan Utsunomiya City Tochigi
028-658-5151
tcog1101@tcog.jp
1st name | |
Middle name | |
Last name | TCOG1101study affairs office |
The Tokyo Cooperative Oncology Group
Clinical Study Promotion Agency
Toa-Bldg 4F 2-1-18 Hamamatsu-cho Minato-ku Toky
03-5401-5020
tcog1101@tcog.jp
The Tokyo Cooperative Oncology Group
The Tokyo Cooperative Oncology Group
Self funding
NO
2012 | Year | 01 | Month | 18 | Day |
Unpublished
Completed
2011 | Year | 11 | Month | 29 | Day |
2011 | Year | 07 | Month | 27 | Day |
2012 | Year | 02 | Month | 01 | Day |
2016 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2012 | Year | 01 | Month | 11 | Day |
2019 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008140
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