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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010443
Receipt No. 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

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Basic information
Public 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
Acronym NJLCG1302 CBDCA + weekly nab-PTX vs CDDP + GEM for SQ-NSCLC patients
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
Scientific Title:Acronym NJLCG1302 CBDCA + weekly nab-PTX vs CDDP + GEM for SQ-NSCLC patients
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Overall Survival
Progression-free Survival
Disease Control Rate
Incidence and Severity of Adverse Events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Shunichi
Middle name
Last name Sugawara
Organization Sendai Kousei Hospital
Division name Department of pulmonary medicine
Zip code 980-0873
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
TEL 022-222-6181
Email swara357@sendai-kousei-hospital.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Kawashima
Organization Sendai Kousei Hospital
Division name Department of pulmonary medicine
Zip code 980-0873
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
TEL 022-222-6181
Homepage URL
Email yousukekawashima3@yahoo.co.jp

Sponsor
Institute North Japan Lung Cancer Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization REC (Research Ethics Committee)
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
Tel 022-222-6181
Email s.takahashi@sendai-kousei-hospital.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 71
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 08 Day
Date of IRB
2013 Year 05 Month 16 Day
Anticipated trial start date
2013 Year 05 Month 17 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 08 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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