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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001810
Receipt No. R000002185
Scientific Title Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Chest Wall: A Phase II Trial
Date of disclosure of the study information 2009/04/01
Last modified on 2018/10/07

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Basic information
Public title Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Chest Wall: A Phase II Trial
Acronym Chemoradiotherapy Followed by Surgery in Treating Patients With Non-Small Cell Lung Cancer Involving the Chest Wall
Scientific Title Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Chest Wall: A Phase II Trial
Scientific Title:Acronym Chemoradiotherapy Followed by Surgery in Treating Patients With Non-Small Cell Lung Cancer Involving the Chest Wall
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase II trail to study the feasibility and effectiveness of concurrent chemotherapy using cisplatin and vinorelbine and radiotherapy followed by surgery in treating patients who have resectable non-small cell lung cancer involving the chest wall.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Three-year survival
Key secondary outcomes Completion rate and objective response rate of induction chemoradiotherapy, Adverse effects of induction chemoradiotherapy, Operability after induction chemoradiotherapy, Complete resection rate, Perioperative morbidity and mortality, Pathologic response, Recurrence patterns, Disease free survival, and Overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Patients receive chemotherapy consisted of Cisplatin 80 mg/m2 day 1 + Vinorelbine 20 mg/m2 days 1 and 8 / 4 weeks x 2 courses

Patients receive also concurrent radiotherapy (Radiation field: Primary tumor, Total dose 40 Gy (2 Gy/day for 4 weeks)).

At 3 to 6 weeks after completion of induction therapy, patients undergo surgical resection (lobectomy or pneumonectomy with mediastinal lymph node dissection combined with chest wall resection).
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically and/or cytologically confirmed non-small cell lung cancer
2.Resectable T3N0-1M0 lung cancer with chest wall invasion including superior sulcus tumor
Criteria for chest wall invasion:
# The tumor obviously invades the soft tissue of the chest wall or ribs at CT.
# The tumor is contiguous to the chest wall at CT, and chest pain and/or positive findings of bone scintigraphy is present at the primary site.
3.No prior therapy
4.Measurable lesions
5.Performance status (ECOG): 0-1
6.Hematopoietic: WBC >3500/ mm3, ANC >1500/ mm3, Hb >=10.0g/dl, Plt >=100000/ mm3
7.Hepatic: T-Bil <=1.5 mg/dl, AST/ALT <80 IU/L
8.Renal: Serum Cr <1.5 mg/dl, CCr >=60 ml/min
9.Pulmonary function: PaO2 >=70 Torr (room air), Predictive postoperative FEV1.0 >=800 ml
10.Written informed consent
Key exclusion criteria 1.N2 disease: Obvious N2 disease at CT/PET, or histologically and/or cytologically confirmed N2 disease by mediastinoscopy and/or EBUS.
2.Active double cancer
3.Prior chemotherapy or radiotherapy
4.Patients with serious comobidities; serious cardiac complications such as uncontrollable angina, myocardial infarction within 3 months, heart failure, arrhythmia required treatment, uncontrollable diabetes mellitus and hypertion, definite interstitial pneumonina, lung fibrosis, and severe emphysema at CT, and infectious diseases.
5.Pregnant or nursing woman
6.V20 more than 30% of normal lung
Target sample size 53

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Yokoi
Organization Nagoya University Graduate School of Medicine
Division name Department of Thoracic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2376
Email k-yokoi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Yokoi
Organization Nagoya University Graduate School of Medicine
Division name Department of Thoracic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2376
Homepage URL
Email k-yokoi@med.nagoya-u.ac.jp

Sponsor
Institute Central Japan Lung Study 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 名古屋大学病院(愛知県)、愛知医科大学病院(愛知県)、豊橋市民病院(愛知県)、栃木県立がんセンター(栃木県)、名古屋医療センター(愛知県)、癌研有明病院(東京都)、公立陶生病院(愛知県)、神奈川県立がんセンター(神奈川県)、小牧市民病院(愛知県)、三重大学病院(三重県)、名古屋第1赤十字病院(愛知県)、名古屋市立大学病院(愛知県)、名古屋第2赤十字病院(愛知県)、長野市民病院(長野県)、豊田厚生病院(愛知県)、三重中央医療センター(三重県)、大垣市民病院(岐阜県)、岐阜大学病院(岐阜県)、愛知県がんセンター中央病院(愛知県)、刈谷豊田総合病院(愛知県)、市立四日市病院(三重県)、藤田保健衛生大学(愛知県)、県立多治見病院(岐阜県)、静岡がんセンター(静岡県)、山形県立中央病院(山形県)、聖隷三方原病院(静岡県)、千葉県がんセンター(千葉県)、大阪府立成人病センター(大阪府)、四国がんセンター(愛媛県)、中京病院(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Kawaguchi K, et al. A prospective, multi-institutional phase II study of induction chemoradiotherapy followed by surgery in patients with non-small cell lung cancer involving the chest wall (CJLSG0801). Lung Cancer 2017;104:79-84.
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
2008 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2017 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
2009 Year 03 Month 29 Day
Last modified on
2018 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002185

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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