UMIN-CTR Clinical Trial

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

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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 or person

Institute

North Japan Lung Cancer Study Group

Institute

Department

Personal name



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

Value
https://center6.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