Unique ID issued by UMIN | UMIN000013706 |
---|---|
Receipt number | R000015800 |
Scientific Title | Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC) |
Date of disclosure of the study information | 2014/04/14 |
Last modified on | 2017/05/16 19:33:36 |
Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)
Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)
Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)
Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)
Japan |
locally advanced maxillary sinus cancer
Hematology and clinical oncology | Oto-rhino-laryngology | Radiology |
Malignancy
NO
To evaluate the safety and the efficacy of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer
Safety,Efficacy
Confirmatory
Phase III
3-year overall survival, The incidence of dose limiting toxicity
Overall survival, Event-free survival, Local event-free survival, Complete clinical remission rate, Adverse events, Serious adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
A: Intra-arterial chemoradiotherapy
Radiotherapy: a total dose of 70 Gy in a fraction of 2 Gy five times weekly
Intra-arterial chemotherapy: CDDP100 mg/m2/day, once a week, 7 times concurrently with radiotherapy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) primary lesion located at maxillary sinus
2) histologically proven squamous cell carcinoma
3) clinical stage T4aN0M0 or T4bN0M0
4) no severe carotid stenosis evaluated by ultrasonography
5) age between 20 and 75 years old (dose finding phase), age between 20 and 80 years old (confirmatory phase),
6) ECOG performance status of 0 or 1
7) no prior therapy for maxillary sinus cancer
8) no prior radiation therapy to the head and neck, and the brain
9) no prior chemotherapy for any other malignancies
10) sufficient organ function
11) normal electrocardiogram
12) suitable for angiography
13) satisfy normal tissue radiation dose constraints such as at least ipsilateral eyeball and optic nerve, spinal cord, brainstem, and chiasma
14) written informed consent.
1) simultaneous or metachronous (within 5 years) double cancers except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers
2) active bacterial or fungous infection
3) body temperature >= 38 degrees Celsius
4) women during pregnancy or breastfeeding
5) psychosis
6) requiring systemic steroids medication or immunosuppressant medication
7) diabetes mellitus poorly controlled
8) poorly controlled hypertension
9) angina pectoris attack within 3 weeks or myocardial infarction within 6 months
10) positive HBs antigen
145
1st name | |
Middle name | |
Last name | Akihiro Homma |
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Department of Otolaryngology-Head and Neck Surgery
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
011-706-5958
ak-homma@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Akihiro Homma |
JCOG1212 Coordinating Office
Department of Otolaryngology-Head and Neck Surgery, Hokkaido University
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
011-706-5958
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)
岩手医科大学(岩手県)
東北大学病院(宮城県)
宮城県立がんセンター(宮城県)
福島県立医科大学附属病院(福島県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
国立病院機構東京医療センター(東京都)
東京医科歯科大学(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)
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)
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)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
奈良県立医科大学(奈良県)
広島大学病院(広島県)
2014 | Year | 04 | Month | 14 | Day |
Unpublished
Open public recruiting
2014 | Year | 02 | Month | 10 | Day |
2014 | Year | 04 | Month | 14 | Day |
2024 | Year | 10 | Month | 14 | Day |
2014 | Year | 04 | Month | 14 | Day |
2017 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015800
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |