UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000012208