UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005448 |
|---|---|
| Receipt number | R000006118 |
| Scientific Title | A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (NPC) (JCOG1015, IMRT for NPC) |
| Date of disclosure of the study information | 2011/04/15 |
| Last modified on | 2022/08/30 16:09:51 |
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Basic information
Public title
A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (NPC) (JCOG1015, IMRT for NPC)
Acronym
A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (NPC) (JCOG1015, IMRT for NPC)
Scientific Title
A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (NPC) (JCOG1015, IMRT for NPC)
Scientific Title:Acronym
A phase II study of intensity modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (NPC) (JCOG1015, IMRT for NPC)
Region
| Japan |
Condition
Condition
Nasopharyngeal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of chemoradiotherapy with Intensity Modulated Radiation Therapy (IMRT) in patients with clinical stage II-IVB nasopharyngeal cancer (UICC 7th edition, 2009)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival (%3-year overall survival for clinical stage II-IVB)
Key secondary outcomes
Progression-free survival (%3-year progression-free survival), locoregional progression-free surival (%3-year locoregional progression-free survival), location of first progression, %completion of protocol treatment, %grade 2 or more dry mouth (evaluated at the 1st, 2nd , 3rd year from IMRT start, CTCAE ver4.0), adverse events
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
| Maneuver |
Interventions/Control_1
Concurrent chemoradiotherapy with two-step IMRT (70 Gy/ 35 fr/ 47 days) and three cycles of cisplatin (80 mg/m2, day 1, q3w) follwed by three cycles of adjuvant chemotherapy with 5-FU (700 mg/m2, day 1-5) plus cisplatin (70 mg/m2, day 1) repeated every 4 weeks.
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
i) Pathologically proven nasopharyngeal cancer based on the biopsy from the tumor or metastatic lymph nodes (either type I, II or III by WHO classification 1978 is eligible) ;
ii) Clinical stage II-IVB (UICC 7th edition, 2009) ;
iii) Aged 20 to 75 years old;
iv) ECOG PS of 0 or 1;
v) No prior chemotherapy against any malignancies, no prior radiation therapy for brain, head or neck resion, no prior surgery for head and neck cancer;
vi) Sufficeient organ functions;
vii) No ECG abnormalities;
viii) Written informed consent.
Key exclusion criteria
i) Simultaneous or metachronous (within 5 years) double cancers;
ii) Systemic infections disease;
iii) Body temperature of 38C or higher;
iv) Women during pregnancy or breast-feeding;
v) Psychiatric disease and/or depression;
vi) Continuous systemic steroids medication;
vii) Histoty of collagen diseases including rheumatism;
viii) Uncontrollable diabetes mellitus or continuous administration of insulin;
ix) treated with hemodialysis;
x) Serious complications (COPD, pulmonary fibrosis, heart failure, etc.);
xi) Myocardial infarction within 6 months or unstable angina pectoris.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumasa Nishimura |
Organization
Kinki University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
Address
377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL
072-366-0221
ynishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumasa Nishimura |
Organization
JCOG1015 Coordinating Office
Division name
Department of Radiation Oncology, Kinki University Faculty of Medicine
Zip code
Address
377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL
072-366-0221
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
札幌医科大学（北海道）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
がん研究会有明病院（東京都）
愛知県がんセンター中央病院（愛知県）
京都大学医学部附属病院（京都府）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006118
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| Registered date | File name |
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| Registered date | File name |
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