Unique ID issued by UMIN | UMIN000013316 |
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Receipt number | R000015535 |
Scientific Title | Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019) |
Date of disclosure of the study information | 2014/03/03 |
Last modified on | 2014/11/11 13:15:47 |
Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019)
Continuous gefitinib beyond PD study(TORG1319)
Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019)
Continuous gefitinib beyond PD study(TORG1319)
Japan |
EGFR positive non-sqamous non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
To compare the efficacy and the safety of chemotherapy + beyond PD gefitinib with those of chemotherapy alone
Safety,Efficacy
Exploratory
Phase II
2 years survival rate after randomization
Frequency of the flare, overall survival, safety, QOL, response rates of 2nd and 3rd line therapies , and progression-free survivals of 2nd and 3rd line therapies
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
1st line: gefitinib, 2nd line: gefitinib + CDDP or CBDCA + pemetrexed, 3rd line: gefitinib + docetaxel , 4th to 6th line: gefitinib + paclitaxel, gemcitabine, or TS-1
1st line: gefitinib, 2nd line: CDDP or CBDCA + pemetrexed, 3rd line: docetaxel, 4th to 6th line: any treatment
20 | years-old | <= |
74 | years-old | >= |
Male and Female
1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer with active EGFR mutations
2)-1. Stage III/ IV patients with postoperative recurrence or non-curative status by radiotherapy
2)-2. Acquired resistance for 1st line gefitinib treatment
3) No prior chemotherapy
4) ECOG performance status 0-1
5) Aged 20 to 74 years old.
6) Adequate organ function
7) Estimated life expectancy at least 3 months
8) at least one measurable lesion
9) Written informed consent by patient
1) Treated by other molecular targeted drug or cytotoxic agent
2) Prior radiation for primary lesions
3) History of steroid therapy for radiation pneumonitis
4) Patients with symptomatic brain metastasis
5) Interstitial pneumonitis or pulmonary fibrosis detectable on CT scan
6) Patient with pleural effusion, pericardial effusion, ascites or superior vena cave
7) With active infection or other serious medical complications
8) Clinically significant allergy
9) With active double cancer
10) Pregnancy or lactating patients
11) Judged to be not suitable by the attending physician
70
1st name | |
Middle name | |
Last name | Kenji Eguchi |
Teikyo university school of medicine
Division of Medical oncology
2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8606
(03)3964-1211
keguchi@med.teikyo-u.ac.jp
1st name | |
Middle name | |
Last name | Nobuhiko Seki |
Teikyo university school of medicine
Division of Medical oncology
2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8606
03-3964-1211
http://www.torg.or.jp
nseki@med.teikyo-u.ac.jp
Thoracic Oncology Research Group
Thoracic Oncology Research Group
Non profit foundation
Japan
NO
2014 | Year | 03 | Month | 03 | Day |
Unpublished
Terminated
2013 | Year | 11 | Month | 27 | Day |
2014 | Year | 03 | Month | 10 | Day |
2018 | Year | 11 | Month | 30 | Day |
2014 | Year | 03 | Month | 03 | Day |
2014 | Year | 11 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015535
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