UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Nobuyuki Katakami
Organization	Kobe City General Hospital
Division name	Division of pulmonary medicine
Address	4-6, Minatojima Nakamachi Chuo-ku,Kobe 650-0046, Japan
TEL	078-302-4321
Email

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2000 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed?term=22674529
Results
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