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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006389
Receipt No. R000007572
Scientific Title A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer
Date of disclosure of the study information 2011/09/21
Last modified on 2016/09/26

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Basic information
Public title A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer
Acronym A Feasibility Study of Trimodality Therapy for Clinical Stage IIIA-N2 NSCLC
Scientific Title A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer
Scientific Title:Acronym A Feasibility Study of Trimodality Therapy for Clinical Stage IIIA-N2 NSCLC
Region
Japan

Condition
Condition 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 To evaluate feasibility of a trimodality therapy consisting preoperative induction chemoradiotherapy (weekly carboplatin [CBDCA] plus paclitaxel [PTX] with concurrent thoracic radiotherapy [50Gy]) as well as feasibility of postoperative consolidation chemotherapy (bolus CBDCA plus PTX) following the trimodality therapy, for resectable clinical stage IIIA-N2 (radiologically suspected and pathological confirmed mediastinal nodal metastasis) non-small cell lung cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete Resection Rate after Surgary following Preoperative Induction Chemo-radiation Therapy
Key secondary outcomes Disease-free Survival Rate at 2 Years
Progression-free Survival Rate at 2 Years
Overall Survival Rate at 2 Years
Effect of Preoperative Chemoradiation Therapy (Objective Radiological Response Rate,and Pathological Evaluation)
Completion Rate of Entire Protocol Treatment Consisting Preoperative Induction Chemoradiotherapy and Surgery followed by Postoperative Adjuvant Chemotherapy
Mortality and Morbidity

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Induction chemo-radiotherapy (weekly carboplatin [CBDCA] plus paclitaxel [PTX] with concurrent radiation [50Gy]) followed by surgery and postoperative consolidation chemotherapy (2 cycles of bolus CBDCA plus PTX)
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologicall or cytologically confirmed non-small cell lung cancer
2) Radiologicall suspected and pathologicall confirmed mediastinal nodal metastasis (N2)
Radiological suspicion of N2 isdefined as follows:
* Enlarged mediastinal node (1cm or more in the short-axis diameter) on CT, or
* Diagnosis of mediastinal nodal metastasis by a radiologist on FDG-PET scan
3) Expected complete tumor resection achieved with (bi-)lobectomy (or pneumonectomy) plus nodal dissection
Ineligible, if a mediastinal involved node showed extra-nodal invasion
4) V20 equal or less than 35% and Expected completion of planned radiation therapy judged by a radiation oncologist, based on 3-dimensional radiation therapy planning
5) No prior therapy for the current lung cancer
6) Patients is >=20 years and <75 years of age at the time of signature of the informed consent
7) ECOG performance status of 0 or 1
8) Expected residual forced expiratory volume in 1 second (FEV1.0) after surgery >=40% of estimated normal (FEV1.0), which was calculated based on each patient's height and weight
9) Adequate major organ function (including bone-marrow, heart, liver, renal function) as assessed by standard laboratory criteria as follows:
White blood cell >=4,000/mm3
Neutrophil >=2,000/mm3
Hemoglobin >=10.0g/dl
Platelet >=100,000/mm3
Serum albumin >=3.0g/dl
Total bilirubin <=1.5 mg/dL
AST, ALT <=100IU/L
Creatinin <=1.2mg/dL
Creatinin clearance >=60mL/min (calculated by the Cockcroft-Gault method, or measured by the 24-hour clearance method)
Arterial oxgen pressure measured by room air respiration (PaO2) >=70mmHg (not substitute for percutaneous oxygen [SpO2])
10) Written informed consent from the patient after adequate explanation of the study prior to the registration
Key exclusion criteria 1) CT revealed apparent extra-nodal invasion
2) The patient has active previous or concomitant malignancies (synchronous malignancies or metachronous malignancies with the disease-free interval of 5years or less), other than cured carcinoma in situ or intramucosal cancer
3) The patiet has uncontrolld hyoertension
4) The patient has uncontrolled diabetes mellitus
5) The patient has symptomatic congestive heart failure, uncontrolled arrhythmia or ischemic heart disease.
6) The patient has uncontrolled gastrointestinal bleeding or peptic ulcer.
7) The patients has active local or systemic infection, which should be treated
8) Positive serum HBs antigen (by quantitative or qualitative evaluation)
9) The patient has continual diarrhea, defined as watery stool (three times or more in one day)
10) The patients has intestinal paralysis or obstruction
11) The patient has a history of severe drug allergy
12) The patients has peripheral sensory or motor neuropathy of grade 2 or more at the time of registration
13) The patient has a history of allergy against agents containing polyoxyethilene oil containing (eg. Cyclosporine injection agent) or platinum agents
14) The patients has agents against alcoholism (eg. Disulfiram, cyanamide)
15) Chest roentogenogram shows apparent interstitial pneumonia or pulmonary fibrosis
16) The patient has persistent systemic (oral or intravenous) or intra-articular administration of steroids
17) The patient has psychiatric disorders that may comprise the patient's ability to comply with the study
18) The patient is pregnant, may be pregnant, or is lacting. The patient, if is of child-bearing potential, does not practice contraception.
19) The patient has a history of previous radiation therapy, and the radiation field is overlapped with the current radiation therapy field
20) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Tanaka
Organization University of Occupational and Environmental Health Hospital
Division name Second Department of Surgery
Zip code
Address 1-1 Iseigaoka, Yahata-nishi-ku, Kitakyusyu, Fukuoka, 807-8555, Japan
TEL 093-691-7442
Email ftanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name datacenter
Zip code
Address Namba Plaza Bldg.3F 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 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
2011 Year 09 Month 21 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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 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
2011 Year 09 Month 21 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007572

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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