Unique ID issued by UMIN | UMIN000008426 |
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Receipt number | R000007469 |
Scientific Title | A Phase I/II Study of Carboplatin, Pemetrexed, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer |
Date of disclosure of the study information | 2012/07/13 |
Last modified on | 2015/01/13 10:45:19 |
A Phase I/II Study of Carboplatin, Pemetrexed, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
A Phase I/II Study of Carboplatin, Pemetrexed, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
A Phase I/II Study of Carboplatin, Pemetrexed, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
A Phase I/II Study of Carboplatin, Pemetrexed, and concurrent Thoracic radiation therapy for Patients with local advanced Non-small cell Lung Cancer
Japan |
local advanced Non-small cell Lung Cancer(non-squamous)
Pneumology |
Malignancy
NO
The aim of the present study is to assess the effectiveness and safety of carboplatin, pemetrexed, and concurrent thoracic radiation therapy for patients with local advanced non-small cell lung cancer.
Safety
Confirmatory
Pragmatic
Phase I,II
Phase I : Safety Dose determination
Phase II : 2-year survival rate
Phase I : Response rate
Phase II : Progression free survival, response rate, disease control rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination of carboplatin:AUC=5 or 6 plus pemetrexed(500mg/m2) with concurrent thoracic radiotherapy 2Gy/day for 30 times
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Patient with pathologically proven non-small cell lung cancer (except for squamous cell carcinoma).
2) Patient with stage III desease who has not been previously treated for lung cancer, including chemotherapy, radiotherapy, and operation
3) Patient who are not candidates for curative operation.
4) Patient who has at least one or more measurable lesion by RECIST. ver.1.1 .
5) An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration.
6) Patient aged 20-74 years old
7) ECOG performance status (PS): 0-1
8) Adequate organ function.
9) Patient who are considered to survive for more than 3 months.
10) Written informed consent.
1) Superior vena cava syndrome.
2) Lymph node metastases of opposite side hilum, malignant pleuritis, malignant pericarditis, lymphangitis.
3) Active infection or other serious disease condition (poorly controlled diabetes mellitus, unstable angina, cardiac infarction, psychological illness, etc.).
4) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
5) With active double cancer.
6) Patient who joins other trial.
7) HBs antigen positive.
8) Severe drug allergy.
9) Pregnancy or lactation.
10) Patient whose participation in the trial is judged to be inappropriate by the attending doctor.
30
1st name | |
Middle name | |
Last name | Hideo Saka |
National hospital organization Nagoya medical center
Respirology
4-1-1 San-no-maru Naka-ku Nagoya city, Aichi prefecture
052-951-1111
saka@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Naohiko Murata |
Central Japan Lung Study Group(CJLSG)
Management office
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
052-744-2167
mnaohiko@med.nagoya-u.ac.jp
Central Japan Lung Study Group(CJLSG)
none
Self funding
NO
2012 | Year | 07 | Month | 13 | Day |
Unpublished
Completed
2011 | Year | 09 | Month | 03 | Day |
2011 | Year | 09 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2012 | Year | 07 | Month | 13 | Day |
2015 | Year | 01 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007469
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