Unique ID issued by UMIN | UMIN000010443 |
---|---|
Receipt number | R000012208 |
Scientific Title | Randomized phase II trial of Carboplatin plus weekly nab-Paclitaxel versus Cisplatin plus Gemcitabine in patients with chemo-naive stage IIIB/IV or postoperative recurrent squamous cell lung cancer |
Date of disclosure of the study information | 2013/04/22 |
Last modified on | 2019/04/15 14:17:42 |
Randomized phase II trial of Carboplatin plus weekly nab-Paclitaxel versus Cisplatin plus Gemcitabine in patients with chemo-naive stage IIIB/IV or postoperative recurrent squamous cell lung cancer
NJLCG1302 CBDCA + weekly nab-PTX vs CDDP + GEM for SQ-NSCLC patients
Randomized phase II trial of Carboplatin plus weekly nab-Paclitaxel versus Cisplatin plus Gemcitabine in patients with chemo-naive stage IIIB/IV or postoperative recurrent squamous cell lung cancer
NJLCG1302 CBDCA + weekly nab-PTX vs CDDP + GEM for SQ-NSCLC patients
Japan |
Non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
To evaluate efficacy and safety of Carboplatin plus weekly nab-Paclitaxel compared with Cisplatin plus Gemcitabine in patients with stage IIIB which curative radiotherapy is not indicated, IV and postoperative recurrent squamous cell lung cancer.
Efficacy
Exploratory
Phase II
Response Rate
Overall Survival
Progression-free Survival
Disease Control Rate
Incidence and Severity of Adverse Events
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 |
Cisplatin 80 mg/m2 is administered intravenously on day 1.
Gemcitabine 1,000 mg/m2 is administered intravenously on days 1, 8.
Treatment is repeated every 3 weeks for 4 cycles or up to 6 cycles by physician's decision.
Carboplatin AUC 6 is administered intravenously on day 1.
Nab-Paclitaxel 75mg/m2 is administered intravenously on days 1, 8, 15.
Treatment is repeated every 3 weeks for 4 cycles or up to 6 cycles by physician's decision.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Histologically or cytologically confirmed squamous cell lung cancer. Non-small cell lung cancer with a predominant squamous component or adenosquamous carcinoma with a predominant squamous component are also acceptable.
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3) No prior chemotherapy (include EGFR-TKI and ALK inhibitor)
*Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted.
*Picibanil use for plural effusion is permitted.
4) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.)
5) At least one measurable lesion (within 28 days before enrollment)
6) Age of 20 to 74 years
7) ECOG Performance status of 0-1
8) Sufficient major organ function as bellow
*Neutrophil count >= 1,500 /mm3
*Platelet count >= 100,000 /mm3
*Hemoglobin >= 9.0 g/dL
*total bilirubin <= 1.5 mg/dL
*AST <= 100 IU/L
*ALT <= 100 IU/L
*Serum creatinine <= 1.5 mg/dL
*Creatinine clearance >= 60 mL/min
(both permit measured CCr and estimated CCr)
*PaO2 >= 60 Torr or more (or SpO2 >= 95% or more)
9) Life expectancy of at least 3 months
10) Written informed consent
1) Previous treatment with gemcitabine and paclitaxel as adjuvant chemotherapy
2) Active double cancer
3) Symptomatic brain metastasis
4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
5) Superior vena cava syndrome
6) Grade 2 or higher peripheral neuropathy
7) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
8) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes)
9)History of Severe drug allergies.
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
11) Physician concludes that the patient's participation in this trial is inappropriate.
70
1st name | Shunichi |
Middle name | |
Last name | Sugawara |
Sendai Kousei Hospital
Department of pulmonary medicine
980-0873
4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
022-222-6181
swara357@sendai-kousei-hospital.jp
1st name | Yosuke |
Middle name | |
Last name | Kawashima |
Sendai Kousei Hospital
Department of pulmonary medicine
980-0873
4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
022-222-6181
yousukekawashima3@yahoo.co.jp
North Japan Lung Cancer Study Group
None
Self funding
REC (Research Ethics Committee)
4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
022-222-6181
s.takahashi@sendai-kousei-hospital.jp
NO
2013 | Year | 04 | Month | 22 | Day |
Unpublished
71
Completed
2013 | Year | 04 | Month | 08 | Day |
2013 | Year | 05 | Month | 16 | Day |
2013 | Year | 05 | Month | 17 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2013 | Year | 04 | Month | 08 | Day |
2019 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012208
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