UMIN-CTR Clinical Trial

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
Email	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/
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006118