Unique ID issued by UMIN | UMIN000002095 |
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Receipt number | R000002558 |
Scientific Title | Phase II study of cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutations (OLCSG0704) |
Date of disclosure of the study information | 2009/08/01 |
Last modified on | 2015/12/20 10:52:18 |
Phase II study of cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutations (OLCSG0704)
CDDP/DOC(/CPT-11), followed by Gefitinib, GEM/VNB for non-small-cell lung cancer patients
Phase II study of cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutations (OLCSG0704)
CDDP/DOC(/CPT-11), followed by Gefitinib, GEM/VNB for non-small-cell lung cancer patients
Japan |
non-small-cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
The objective is to evaluate overall survival, progression-free survival, objective response rate and safety of the sequential treatment (cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine) for the patients with advanced non-small cell lung cancer harboring active EGFR mutations.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Overall survival
Response rate, progression-free survival, adverse events, treatment compliance, relationship between response rate and expression levels of ERCC1 and thioredoxin in the tumors, Comparison of outcomes with EGFR mutation negative patients
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Cisplatin, docetaxel, (and irinotecan), followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutation
Not applicable |
65 | years-old | >= |
Male and Female
Histologically and/or cytologically proven NSCLC
No prior surgery, chemotherapy, or radiotherapy
Age ≤ 65
Stage IIIB (unfit for curative thoracic radiation) or IV
ECOG performance status 0 or 1
Measurable disease
Ample bone marrow, lung, hepatic, and renal function
Signed informed consent
Symptomatic brain metastasis, Symptomatic malignant pleural/pericardial effusion
Active concomitant malignancy
Unstable angina, recent myocardial infarction, heart failure
Uncontrolled diabetes or hypertension
Pregnant or lactating women
Other severe complications
30
1st name | |
Middle name | |
Last name | Katsuyuki Kiura |
Okayama University Hospital
Respiratory Medicine
2-5-1 Shikata-cho, Okayama
086-235-7225
kkiura@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Nagio Takigawa |
Okayama Lung Cancer Study Group
Office
2-5-1 Shikata-cho, Okayama
086-235-7227
ntakigaw@md.okayama-u.ac.jp
Okayama Lung Cancer Study Group
Self funding
Self funding
NO
2009 | Year | 08 | Month | 01 | Day |
Unpublished
Terminated
2007 | Year | 12 | Month | 03 | Day |
2007 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2009 | Year | 06 | Month | 19 | Day |
2015 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002558
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