UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000031 |
|---|---|
| Receipt number | 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 14:00:22 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000066
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