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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000174
Receipt No. R000000246
Scientific Title A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.
Date of disclosure of the study information 2005/09/14
Last modified on 2016/04/26

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Basic information
Public title A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.
Acronym Phase III trial of chemotherapy versus chemoradiotherapy before surgery in stage IIIA-N2 NSCLC
Scientific Title A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.
Scientific Title:Acronym Phase III trial of chemotherapy versus chemoradiotherapy before surgery in stage IIIA-N2 NSCLC
Region
Japan

Condition
Condition Pathologically confirmed stage IIIA-N2 non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of the multicenter randomized phase III study is to evaluate the safety and effectiveness of preoperative chemotherapy or concurrent chemoradiotherapy followed by surgery in patients with pathologically-proved stage IIIA-N2 non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Five-year survival
Key secondary outcomes toxicity of a preoperative treatment and a response rate, resection rate, complete resection rate, unresectable rate, downstaging rate, postoperative mortality and morbidity, hospital mortality, disease-free survival rate, median survival time, pattern of recurrence (first site of relapse)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bimodality therapy group: two courses of systemic chemotherapy followed by surgeryTrimodality therapy group: two courses of systemic chemotherapy with concurrent thoracic radiotherapy followed by surgeryChemotherapy regimen consists of carboplatin and docetaxel on day 1. Two courses of chemotherapy with 3 weeks interval is plannedPatients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy.
Interventions/Control_2 Radiotherapy begins on day 1, concurrently with chemotherapy.(The total dose of radiation is 40 Gy, 2 Gy/fraction/day)
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Pathological diagnosis of non-small cell lung cancer is necessary. Ipsilateral pathologically-proved mediastinal lymph node with shortest diameter of larger than 1 cm is required.2) Pretreatment lesions are respectable without extranodal invasion. 3) No prior treatment for lung cancer4) Measurable disease5) Age 20 to 70 years6) Performance status (ECOG criteria) 0-17) Adequate organ functions
WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul, T.Bil less than 1.5mg/dl, serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 40mg/dl, PaO2 more than 70torr, Forced expiratory volume in 1 secnd more than 1.5L
8) No prior chemotherapy or radiotherapy for the treatment of other malignancies is essential.9) Written informed consent to participate in the trial is necessary
Key exclusion criteria 1)Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of completely resected early gastric cancer,uterine cervical cancer, completely resected skin malignancies (except malignant melanoma)are acceptable.
2)Uncontrollable angina or myocardial infarction within the past 3 months. Severe heart disease, arrhythmia requiring treatment.
3)Uncontrollable hypertension and Diabetes Mellitus.
4)Patients with severe COPD (FEV1.0percent less than 65)or pulmonary fibrosis recognized with computed tomography scanning.
5)Weight loss more than 10 percent within the past 6 months
6)Women during pregnancy or lactating.
7)ther unsuitable patient judged by a physician.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Kobe City General Hospital
Division name Division of pulmonary medicine
Zip code
Address 4-6, Minatojima Nakamachi Chuo-ku,Kobe 650-0046, Japan
TEL 078-302-4321
Email

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.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology 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
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
2005 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed?term=22674529
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 Completed
Date of protocol fixation
2000 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2016 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000246

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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