Unique ID issued by UMIN | UMIN000009308 |
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Receipt number | R000010930 |
Scientific Title | Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer. |
Date of disclosure of the study information | 2013/01/01 |
Last modified on | 2017/11/14 09:07:48 |
Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Japan |
Squamous cell carcinoma of the lung
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and feasibilty for Carboplatin and alternate-day administrations of TS-1 in patients with squamous cell lung cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Disease control rate (CR+PR+SD)
1.Overall survival
2.Progression-free survival from induction chemotherapy
3.Progression-free survival from maintenance chemotherapy
4.Percrntages of patients who received maintenance chemotherapy
5.Response rate
6.Toxicities
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Induction chemotherapy with Carboplatin and alternate-day administrations of TS-1
for all registered patients.
Maintenance chemotherapy with alternate-day administrations of TS-1 for non-PD patients.
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically or cytologically confirmed squamous cell carcinoma of the lung
2.Stage IIIB/IV
3.Age >=20
4.PS(Eastern Cooperative Oncology Group:ECOG):0-2
5.Measurable lesion
6.Capable of oral intake
7.Adequate organ functions
neutrophils >=1,500/mm3
platelets >=100,000/mm3
hemoglobin >=9.0g/dL
total bilirubin <=2.0mg/dL
AST(GOT)/ALT(GPT) <=100IU/L
PaO2 >= 60torr or SpO2 >=90%
creatinine clearance >=30mL/min
8.Estimated life expectancy of at least 3 months
9.With written informed consent
1.Contraindication of TS-1, CBDCA
2)Patients received adjuvant chemotherapy
3.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
4.Active infection
5.HBs antigen positive
6.Severe complications, such as ileus, heart failure and renal failure
7.Continuous diarrhea
8.Massive pleural effusion and ascites
9.Active concomitant malignancy
10.Patients under treatment with flucytosine, phenytoin or warfarin potassium
11.Patients under treatment with steroids
12.Inadequate physical condition, as diagnosed by primary physician
35
1st name | |
Middle name | |
Last name | Young Hak Kim |
Kyoto University Hospital
Respiratory Medicine
54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
075-751-3830
ekim@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Nagai |
Kyoto University Hospital
Respiratory Medicine
54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
075-751-3830
hwithe@kuhp.kyoto-u.ac.jp
Kyoto Thoracic Oncology Research Group
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
NO
京都大学附属病院(京都府)
2013 | Year | 01 | Month | 01 | Day |
Unpublished
Open public recruiting
2012 | Year | 11 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2012 | Year | 11 | Month | 10 | Day |
2017 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010930
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