Unique ID issued by UMIN | UMIN000011663 |
---|---|
Receipt number | R000011565 |
Scientific Title | Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer |
Date of disclosure of the study information | 2013/09/05 |
Last modified on | 2013/09/06 12:44:31 |
Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer
Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer
Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer
Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer
Japan |
Unresectable locally advanced non-small cell lung cancer
Pneumology |
Malignancy
NO
To determine recommended dose, efficacy, and safety of carboplatin, TS-1, and concurrent radiation therapy in patients with locally advanced non-small cell lung cancer
Safety,Efficacy
Phase II
Phase I study: MTD, RD
Phase II study : Response rate in RD
Phase I study: Safety, RR
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-1:50mg/m2(day1-14)+
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
Level1
CBDCA :AUC5(day1)+
S-1:50mg/m2(day1-14)+
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
Level2
CBDCA :AUC5(day1)+ S-1:65mg/m2(day1-14)
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
Level3
CBDCA :AUC5(day1)+
S-1:80mg/m2(day1-14)
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Patients with histlogically or cytologically confirmed non-small cell lung cancer
2)Patients with clinical unresectable stage IIIA or IIIB
3) 20<=, <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)No prior chemotherapy nor radiation therapy
8)Adequate bone marrow reserve and organ function
9)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 allergic reaction with CBDCA or other platinum-containing drug
8) History of serious allergic reaction with S-1
9) Being treated with other pyrimidine fluoride antineoplastic agents.
10) Being treated with flucytosine.
11) Any patients judged by the investigator to be unfit to participate in the study
40
1st name | |
Middle name | |
Last name | Yoshiki Ishii |
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
ishiiysk@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Yoshiki Ishii |
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
ishiiysk@dokkyomed.ac.jp
Dokkyo Medical University
Dokkyo Medical University
Self funding
NO
2013 | Year | 09 | Month | 05 | Day |
Unpublished
Open public recruiting
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 05 | Day |
2013 | Year | 09 | Month | 05 | Day |
2013 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011565
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