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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030598
Receipt No. R000034942
Scientific Title Docetaxel plus Ramucirumab with pegylated granulocyte-colony stimulating factor support for elderly patients with advanced non-small cell lung cancer: A multicenter prospective single arm phase II study: DRAGON study(WJOG9416L)
Date of disclosure of the study information 2017/12/27
Last modified on 2018/02/05

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Basic information
Public title Docetaxel plus Ramucirumab with pegylated granulocyte-colony stimulating factor support for elderly patients with advanced non-small cell lung cancer: A multicenter prospective single arm phase II study: DRAGON study(WJOG9416L)
Acronym DOC+RAM+PEG-G-CSF in elderly NSCLC
Scientific Title Docetaxel plus Ramucirumab with pegylated granulocyte-colony stimulating factor support for elderly patients with advanced non-small cell lung cancer: A multicenter prospective single arm phase II study: DRAGON study(WJOG9416L)
Scientific Title:Acronym DOC+RAM+PEG-G-CSF in elderly NSCLC
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Geriatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of DOC+RAM with PEG-G-CSF support in chemo-naive elderly patients (aged 75) with NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival, overall survival, and safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DOC(60 mg/m2, day 1)+ RAM(10 mg/kg, day 1)&PEG-G-CSF(3.6 mg, day 2-4) every 3 weeks until progression or both DOC and RAM termination
Interventions/Control_2
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Aged <= 75
2.Written informed consent
3.Histologically or cytologically confirmed NSCLC
4.Stage IIIb without indication of definitive chemoradiotherapy, stage IV, or recurrence after surgery
5.Presence of measurable lesions
6.No symptomatic brain metastases and/or spiral metastases with requirement of surgery
7.No symptomatic superior vena cava syndrome
8.No uncontrolled cardiac, pleural, or abdominal effusion
9.No radiographic findings of ramucirumab restriction
I. No cancer invasion to major vessels and/or major vessel stenosis
II. No cavitation regardless of histology
III. No tumor exposure to main bronchus
10.ECOG PS 0/1
11.Normal labo data
WBC >= 3,000/mm3
Neut >= 1,500/mm3
Hb >= 9.0 g/dL
Plt >= 10 x 10^4 / mm3
T-bil <= 1.5 mg/dL
AST/ALT <= 100 IU/L (<= 200 IU/L by liver metastases)
CRE <= 1.5 mg/dL
PT-INR <= 1.5
SpO2 <= 92%
Protein uria <= 1+
12.No active hepatitis B infection
13.No history of receiving cytotoxic chemotherapies and ramucirumab
14.Recurrent cases after surgery, 1 prior adjuvant chemotherapy is permitted
15.No history of recent surgery
16.Interval >= 7 days after palliative radiation therapies
17.No prior chest radiotherapy for primary disease
18.No history of chest radiotherapy and chemotherapy against cancers other than primary disease
Key exclusion criteria 1) Active multiple cancer
2) Active infection
3) Interstitial pneumonia/pulmonary fibrosis
4) Uncontrolled diabetes
5) Uncontrolled hypertension
6) Clinically significant heart failure or uncontrolled arythmia
7) Ileus, inflammatory bowel disease, or chronic diarrhea
8) Uncontrolled thromboembolism
9) HIV associated disease
10) Severe psychological disease
11) Severe liver dysfunction such as cirrhosis
12) Prescription of steroids and/or immunosuppressant
13) Anticoaglation with warfarin or heparin
14) Prescription of long-term NSAIDS or antiplatelets
15) Fever >= 38.0 degrees C
16) Recent history of hemoptysis
17) Recent history of cardio-brain vascular disease
18) Incurable wound, ulcer, or bone fracture
19) Recent history of bleeding, vasculitis, or gastrointestinal hemorrhage
20) Recent history of gastrointestinal perforation/fistula
21) History of hypersensitivity by agents containing polysorbate 80
22) Plan of major surgery during the trial
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akito Hata
Organization Kobe City Medical Center General Hospital
Division name Department of Medical Oncology
Zip code
Address 1-1, 2 chome, Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo
TEL 078-302-4321
Email akito_hata@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization Eli Lilly Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 27 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
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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 27 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034942

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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