Unique ID issued by UMIN | UMIN000000913 |
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Receipt number | R000001102 |
Scientific Title | Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer |
Date of disclosure of the study information | 2007/11/29 |
Last modified on | 2019/06/11 17:54:32 |
Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Randomized phase II trial of CBDCA/GEM versus CDDP/GEM for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Randomized phase II trial of CBDCA/GEM versus CDDP/GEM for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Japan |
Non Small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the relapse free survival of completely resected non-small cell lung cancer with adjuvant chemotherapy (CDDP+GEM vs CBDCA+GEM)
Safety,Efficacy
Exploratory
Pragmatic
Phase II
2-year relapse free survival
Safety
Feasibility
Overall survival time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
adjuvant chemotherapy with CDDP+GEM
adjuvant chemotherapy with CBDCA+GEM
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. pathologically proven non-small cell lung cancer
2. complete resection
3. pathological stage IB, II, and stage IIIA
4. no prior anti cancer treatment for thoracic malignancy except for this operation
5. Performance status(ECOG)0-1
6. adequate organ function for chemotherapy
7. written informed consent
1. sever infection
2. uncontrolled Diabetes Mellitus and hypertension, unstable angina or Myocardial Infarction within 6 months
3. apparent interstitial pneumonitis at chest rentogenogram
4. Uncontrollable pleural effusion
5. multiple lung cancer or other-type cancer within 5 years
6. History of severe hypersensitivity
7. Pregnant or expecting woman
102
1st name | Masao |
Middle name | |
Last name | Harada |
Hokkaido Lung Cancer Clinical Study Group
Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center
0030804
4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan
011-811-9111
fukumoto.shinichi.ad@mail.hosp.go.jp
1st name | Shin-ichi |
Middle name | |
Last name | Fukumoto |
Hokkaido Lung Cancer Clinical Study Group
Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center
0030804
4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan
011-811-9111
fukumoto.shinichi.ad@mail.hosp.go.jp
Hokkaido Lung Cancer Clinical Study Group
None
Self funding
National Hospital Organization Hokkaido Cancer Center
4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan
011-811-9111
fukumoto.shinichi.ad@mail.hosp.go.jp
NO
2007 | Year | 11 | Month | 29 | Day |
Unpublished
Main results already published
2007 | Year | 10 | Month | 20 | Day |
2007 | Year | 10 | Month | 17 | Day |
2007 | Year | 11 | Month | 01 | Day |
2014 | Year | 08 | Month | 09 | Day |
2007 | Year | 11 | Month | 29 | Day |
2019 | Year | 06 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001102
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