Unique ID issued by UMIN | UMIN000008083 |
---|---|
Receipt number | R000009518 |
Scientific Title | A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102) |
Date of disclosure of the study information | 2012/06/01 |
Last modified on | 2018/12/17 10:13:52 |
A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
Japan |
Chemo-Naïve Patients with Squamous Cell Lung Cancer
Pneumology |
Malignancy
NO
To investigate the efficacy and safety of Carboplatin plus oral S1 followed by maintenance S1 treatment in Chemo-Naive Patients stage IIIB/IV with Squamous Cell Lung Cancer
Safety,Efficacy
Phase II
Response rate
Progression-free survival, Progression-free survival of maintenance treatment, Overall survival, Frequency and grade of adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin AUC = 5(day1)+ S-1 80mg/m2 (day1~14) q3weeks 6 cycles followed by +S-1 80mg/m2(day1~14) q3weeks until disease progression
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically or cytologically confirmed squamous cell lung cancer
2.Stage IIIB/IV without any indications for radiotherapy, or recurrent disease after surgery
3.Measurable disease
4.Except for the surgical treatment for non-small cell lung cancer, patients have not been conducted prior treatment (radiation therapy, and chemotherapy)However, radiation therapy is not applied radiation field in the primary tumor, two weeks after irradiation final at the time of registration it is acceptable)
5.Age 20=<
6.ECOG performance status of 0 to 1
7.Patiants who can take in drug orally
8.Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 3,500 /mm3
Neu >= 1,500 /mm3
Plt >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
AST (GOT) , ALT (GPT) =< 100 IU/L
T. bil =< 1.5 mg/dL
Cr >= 1.2mg/dL
SpO2 >= 90% or >= 60 torr
9.Expected to live over 12 weeks after administration days
10.Written informed consent from the patients
1.Adjuvant chemotherapy
2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia.
3.History of severe drug allergy
4.Active synchronous malignancies
5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
6.Severe complication
7.Metastasis to CNS
8.Patients with chest radiation treatment is required to reach the lung irradiation
9.Treated by flucytosine (5-FC)
10.Women with a possibility of pregnancy, pregnant or lactating
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
35
1st name | |
Middle name | |
Last name | Takashi Kijima |
Osaka University Hospital
Dept. of Respiratory Medicine
2-15 Yamada-oka, Suita, Osaka, Japan
06-6879-3833
tkijima@imed3.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Takashi Kijima |
Osaka University Hospital
Dept. of Respiratory Medicine
2-15 Yamada-oka, Suita, Osaka, Japan
06-6879-3833
tkijima@imed3.med.osaka-u.ac.jp
Dept. of Respiratory Medicine,
Osaka University Hospital
Dept. of Respiratory Medicine,
Osaka University Hospital
Self funding
OSAKA-LCSG
NO
2012 | Year | 06 | Month | 01 | Day |
Published
In the 33 patients analyzed, the rate of patients who met the primary endpoint was 30.3% (95% confidence interval: (15.6%-48.7%), and the disease control rate was 75.8%. The median PFS and OS were 3.5 and 11.3 months, respectively. Ten patients received maintenance S-1, and the median PFS from the beginning of induction treatment was 5.3 months. Grade 3/4 toxicities with a frequency of more than 5% were all controllable.
Completed
2010 | Year | 12 | Month | 01 | Day |
2012 | Year | 04 | Month | 01 | Day |
2014 | Year | 01 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2012 | Year | 06 | Month | 01 | Day |
2018 | Year | 12 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009518
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |