Unique ID issued by UMIN | UMIN000009275 |
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Receipt number | R000010895 |
Scientific Title | PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC. |
Date of disclosure of the study information | 2012/11/06 |
Last modified on | 2012/11/06 22:54:41 |
PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Japan |
Non Squamous Non Small Cell Lung Cancer
Pneumology |
Malignancy
NO
Phase II study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Progression Free Survival
Overall Survival,
Response Rate,
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TS-1 is given in a dose of 40-60 mg/m2 (adjusted to body surface area) twice daily (morning and evening) for 14 consecutive days followed by a 7-day rest. This 3-week period is regarded as one cycle. Treatment is repeated until termination criteria.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically confirned advanced non-small-cell lung cancer (NSCLC)
2)stage IV or postoperative recurrence patients
3)Patients previously treated with platinum- based chemotherapy for four cycles and except PD cases
4)more than 20 years old
5)ECOG PS 0-2
6)Measurable lesion
7)Adequate organ function
8)patients who can take orally
9)Signed informed consent
1)Interstitial pneumonia or pulmonary fibrosis on chest X-ray
2) History of serious drug allergy
3)Patients with active double cancer 4)Patients with pleural or pericardial effusion ,or ascites
5)Being treated with flucytosine.
6) History of serious infection
7)History of HBs antigen
8)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)
9 )Symptomatic brain metastases
10)Patients with pregnancy or lactation
11)patients whom it is judged to have difficulty in participation in study because of psychosis or neurologic disease
12)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
22
1st name | |
Middle name | |
Last name | TAKASHI YOKOI |
Kansai Medical University Hirakata
Hospital
Respiratory medicine
2-3-1 Shin-machi, Hirakata-shi, Osaka 573-1191 JAPAN
1st name | |
Middle name | |
Last name |
Kansai Medical University Hirakata Hospital
Respiratory medicine
yokoit@hirakata.kmu.ac.jp
Kansai Medical University
Kansai Medical University
Self funding
NO
関西医科大学附属枚方病院(大阪府)
2012 | Year | 11 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 11 | Month | 06 | Day |
2012 | Year | 11 | Month | 06 | Day |
2012 | Year | 11 | Month | 06 | Day |
2012 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010895
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