Unique ID issued by UMIN | UMIN000012455 |
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Receipt number | R000014575 |
Scientific Title | Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer |
Date of disclosure of the study information | 2013/12/02 |
Last modified on | 2013/12/02 06:56:45 |
Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Japan |
non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
evaluate the efficacy and safety of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
2 years survival rate
Response rate, Progression-free survival, Overall survival, Surgery transition rate, Rate and incidence of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
S-1:80mg/m2 (d1-d15)
q4w x 4 cycles
CDDP:60 mg/m2(d1)
q4w x 4 cycles
RT: 66 Gy/33frs
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Patients with histlogically or cytologically confirmed non-small cell lung cancer
2) Prior treatment of radiotherapy, chemotherapy or surgery for Patients with stage IIIA or IIIB
3)Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated
4) Unresectable lung cancer
5) 20<=, <80years old
6)PS:0-1 (ECOG)
7)adequate bone marrow,liver,and renal functions
WBC count >= 4,000/mm3,
Neutrophil counts >= 2,000/mm3
Platelets >= 100,000/mm3
Hemoglobin concentration >= 9.0g/dL
Total bilirubin <= 1.5mg/dL
AST and ALT >=100IU/L
SpO2(Room air) >=90%
Creatinine clearance >= 60 mL/min,
8)written informed consent
1) SVC syndrome
2)Active infection more than and equal to grade 2
3) Continuous watery diarrhea
4) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease
5) Continuous administration of a steroid
6) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free
7) Pregnant status or lactation
8) Uncontrolled psychiatric disease 9) Patients required for continuing steroid therapy
10) Severe drug allergy
11) Being treated with flucytosine.
12)Participation in other registration trial before randomization in this trial
13) Any patients judged by the investigator to be unfit to participate in the study
24
1st name | |
Middle name | |
Last name | Toshinari Ema |
Itabashi central medical center
Department of Thoracic Surgery
2-12-7 Azusawa, Itabashi, Tokyo 174-0051
03-3967-0572
toshinariema09@yahoo.co.jp
1st name | |
Middle name | |
Last name | Toshinari Ema |
Itabashi central medical center
Department of Thoracic Surgery
2-12-7 Azusawa, Itabashi, Tokyo 174-0051
03-3967-0572
toshinariema09@yahoo.co.jp
Itabashi central medical center
None
Self funding
NO
2013 | Year | 12 | Month | 02 | Day |
Unpublished
Open public recruiting
2013 | Year | 12 | Month | 02 | Day |
2013 | Year | 12 | Month | 02 | Day |
2016 | Year | 11 | Month | 01 | Day |
2013 | Year | 12 | Month | 02 | Day |
2013 | Year | 12 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014575
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