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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000031
Receipt No. R000000066
Scientific Title A phase II trial of pre-operative chemoradiotherapy followed by surgical resection in Pancoast tumors: initial report of Japan Clinical Oncology Group trial (JCOG 9806)
Date of disclosure of the study information 2005/07/28
Last modified on 2014/08/13

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Basic information
Public title A phase II trial of pre-operative chemoradiotherapy followed by surgical resection in Pancoast tumors: initial report of Japan Clinical Oncology Group trial (JCOG 9806)
Acronym A phase II trial of pre-operative chemoradiotherapy followed by surgical resection in Pancoast tumors: initial report of Japan Clinical Oncology Group trial (JCOG 9806)
Scientific Title A phase II trial of pre-operative chemoradiotherapy followed by surgical resection in Pancoast tumors: initial report of Japan Clinical Oncology Group trial (JCOG 9806)
Scientific Title:Acronym A phase II trial of pre-operative chemoradiotherapy followed by surgical resection in Pancoast tumors: initial report of Japan Clinical Oncology Group trial (JCOG 9806)
Region
Japan

Condition
Condition pulmonary neoplasm
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-year survival rate
Key secondary outcomes complete resection rate, post-surgical morbidity/mortality, local control rate

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 Preoperative mytomicin C-vindesine-cisplatin combination chemotherapy and thoracic radiotherapy
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
15 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Newly diagnosed, pathologically documented NSCLC
Invasion to the first rib or more superior chest wall
Age: 15-74 years old
ECOG performance status 0 or 1
Ample organ function
No prior chemo-or radiotherapy
Signed informed consent
Key exclusion criteria Metastasis to, or involvement of, mediastinal node (N2)
Distant metastasis or dissemination to pleura/pericardium
Active concomitant malignancy
Unstable angina, recent myocardial infarction, heart failure
Uncontrolled diabetes or hypertension
Pregnant or lactating women
Other severe complications
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Harubumi Kato, M.D., Ph.D.
Organization Tokyo Medical University
Division name First Department of Surgery
Zip code
Address 6-7-1 Nishishinnjuku, Shinjuku-ku, Tokyo, 160-0023, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Kunitoh, M.D.
Organization JCOG9806 Coordinating Office
Division name Medical Oncology Division, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00128037
Org. issuing International ID_1 ClinicalTrials.gov by NLM
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 07 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/18235125
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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
1998 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
1999 Year 05 Month 01 Day
Last follow-up date
2005 Year 11 Month 01 Day
Date of closure to data entry
2006 Year 02 Month 01 Day
Date trial data considered complete
2006 Year 02 Month 01 Day
Date analysis concluded
2006 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 07 Month 28 Day
Last modified on
2014 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000066

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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