Unique ID issued by UMIN | UMIN000014274 |
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Receipt number | R000016433 |
Scientific Title | A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC) |
Date of disclosure of the study information | 2014/06/16 |
Last modified on | 2021/01/05 16:18:06 |
A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)
A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)
A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)
A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)
Japan |
Oropharyngeal cancer
Oto-rhino-laryngology | Radiology |
Malignancy
NO
To evaluate the efficacy and the safety of radiotherapy with Intensity Modulated Radiation Therapy (IMRT) in patients with T1-2N0-1M0 (UICC 7th edition, 2009) oropharyngeal cancer (Tonsil without base of tongue invasion, Base of tongue, Soft palate)
Efficacy
Confirmatory
Phase III
Overall survival (%3-year overall survival)
Progression-free survival (%3-year progression-free survival), loco-regional progression-free survival (%3-year loco-regional progression-free survival), loco-regional control (%3-year loco-regional control), site of first progression, proportion of protocol treatment completion within recommended treatment time, grade 2 or more xerostomia (evaluated at 3, 6, 12, 18, 24, 36 months from IMRT start, CTCAE ver4.0-JCOG), adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Radiotherapy with two-step IMRT (70 Gy/ 35 fr/ 47 days).
20 | years-old | <= |
80 | years-old | >= |
Male and Female
i) Clinically diagnosed of oropharyngeal cancer
ii) Pathologically proven squamous cell carcinoma based on the biopsy from the tumor
iii) Subsites including tonsil without invasion to the base of tongue, base of the tongue, or soft palate
iv) cT1-2N0-1M0 (UICC 7th edition, 2009), no synchronous double/multiple cancer
v) In case of cN0, not a candidate for transoral approach surgery
vi) Planned treatment period within 52 days
vii) Aged 20 to 80 years old
viii) ECOG PS of 0 or 1
ix) No prior chemotherapy for any malignancies, no prior radiation therapy for brain, head or neck region, no prior surgery for head and neck cancer
x) Sufficient organ functions
xi) Written informed consent
i) Simultaneous or metachronous (within the past 5 years) malignancies
ii) Infectious disease requiring systemic treatment
iii) Body temperature of 38 degrees Celsius or higher
iv) Pregnant or lactating women or women of childbearing potential
v) Psychiatric disease
vi) Continuous systemic steroids or immunosuppressive medication
vii) History of collagen diseases including rheumatism
viii) Diabetes mellitus treated with routine administration of insulin or poorly controlled
ix) Treated with hemodialysis
x) Serious complications (COPD, pulmonary fibrosis, heart failure, etc.)
xi) Myocardial infarction within 6 months or unstable angina pectoris
xii) Cardiac pacemaker or ICD recipients
57
1st name | |
Middle name | |
Last name | Yasumasa Nishimura |
Kinki University Faculty of Medicine
Department of Radiation Oncology
377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan
072-366-0221(3132)(3130)
ynishi@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Satoaki Nakamura |
JCOG1208 Coordinating Office
Department of Radiation Oncology, Kansai Medical University Hospital
2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan
072-804-0101
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
Japan Agency for Medical Research and Development
Other
Japan
NO
北海道大学病院(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
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)
千葉大学医学部(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
昭和大学病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
静岡県立静岡がんセンター(静岡県)
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)
兵庫県立がんセンター(兵庫県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
九州大学病院(福岡県)
2014 | Year | 06 | Month | 16 | Day |
Unpublished
No longer recruiting
2014 | Year | 04 | Month | 07 | Day |
2014 | Year | 05 | Month | 22 | Day |
2014 | Year | 06 | Month | 16 | Day |
2023 | Year | 03 | Month | 16 | Day |
2014 | Year | 06 | Month | 16 | Day |
2021 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016433
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