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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000599
Receipt No. R000000697
Scientific Title A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer
Date of disclosure of the study information 2007/02/08
Last modified on 2019/08/22

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Basic information
Public title A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer
Acronym A phase II study of preoperative concurrent chemoradiotherapy for
non-small-cell lung cancer
Scientific Title A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer
Scientific Title:Acronym A phase II study of preoperative concurrent chemoradiotherapy for
non-small-cell lung cancer
Region
Japan

Condition
Condition resectable locally advanced non small cell lung cancer
Classification by specialty
Pneumology Surgery in general Chest surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present study is planned to assess the feasibility and effectiveness of the chemoradiotherapy as preoperative treatment in patients with stage IIIA or IIIB disease of which mediastinal lymph node metastasis is confirmed pathologically by mediastenoscopy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-year survival
Key secondary outcomes the rate of complete resection
pathological response of preoperative therapy(down staging, pathological CR)
Progression free survival
toxicities

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
Interventions/Control_1 Two courses of chemotherapy with cisplatin (40 mg m-2) and docetaxel (40 mg m-2) with 3 weeks interval is planned. A total radiation dose of 40 Gy is planned with conventional fractionation (2 Gy day-). Patients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy.
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria a) Pathological diagnosis of non-small cell lung cancer is necessary. Lesions should be surgically respectable.
b) Age = or < 70 years
c) No prior treatment for lung cancer
d) stage IIIA or IIIB with pathologically-proved mediastinal lymph node. Patients with mediastinal LN of shortest diameter of larger than 1 cm, T2-4, or CEA > 10ng/ml are required to undergo mediastinoscopy. Mediastinal lymph node biopsy should be done for bilateral #1-4, and #7.
e) Performance status (ECOG criteria) 0-1
f) Resection index should be more than 30.
g) No other primary cancers within past 5 years and no active cancers
h) Adequate bone marrow function
WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul.
i) Adequate liver function
(T.Bil less than 1.5mg/dl, AST/ALT less than 2.5 times of normal range.)
j) Adequate renal level. (serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 60mg/dl)
k) Adequate pulmonary function
(PaO2 more than 70torr)
l) No other severe complications. Agreement for the protocol by physicians, surgeons and radiologists is essential.
m) Written informed consent to participate in the trial is necessary
Key exclusion criteria a) Malignant pleuritis or malignant pericarditis.
b) Pleural dissemination.
c) Positive suplra calavicle nodes.
d) Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of chemotherapy or thoracic irradiation are not acceptable.
e) Patients with severe complications.
1) Pulmonary fibrosis recognized with computed tomography scanning.
2)Severe heart disease.(Uncontrollable angina or myocardial infarction within the past 3 months)
3) Uncontrollable Diabetes Mellitus.
4) Severe infectious disease
5) Other unsuitable patient judged by a physician.
f) Women during pregnancy or lactating.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Toyooka
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Thoracic, Breast and Endocrine Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-7265
Email toyooka@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Hiromasa
Middle name
Last name Yamamoto
Organization Okayama University Hospital
Division name Department of Thoracic Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-7265
Homepage URL
Email h.yamamoto@md.okayama-u.ac.jp

Sponsor
Institute Setouchi Lung Cancer 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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.jp

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
2007 Year 02 Month 08 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 1
Results
Unpublished
Results date posted
2019 Year 08 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2007 Year 01 Month 20 Day
Date of IRB
2010 Year 10 Month 25 Day
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2011 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
2007 Year 02 Month 07 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000697

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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