Unique ID issued by UMIN | UMIN000012039 |
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Receipt number | R000012837 |
Scientific Title | A phase I/II clinical trial of pelvic carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix |
Date of disclosure of the study information | 2013/10/17 |
Last modified on | 2021/04/21 15:20:01 |
A phase I/II clinical trial of pelvic carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Cervix-VI (Protocol 1302)
A phase I/II clinical trial of pelvic carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Cervix-VI (Protocol 1302)
Japan |
Uterine cervical cancer
Obstetrics and Gynecology | Radiology |
Malignancy
NO
To evaluate the saftey and the toxicity of prophylactic radiotherapy of pelvic lymph nodes using carbon ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Safety,Efficacy
Confirmatory
Explanatory
Phase I,II
Acute toxicity
2-year progression free survival
The ratio of the patients who completed the course
Acute and late toxicies
Response rate of the local
Local control rate
Overall survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
5 weeks
Carbon ion radiotherapy: 72.0 GyE / 20 fractions
Chemotherapy: weekly cisplatin 30-40 mg / m2 for 5 weeks.
20 | years-old | <= |
70 | years-old | >= |
Female
1. Squamous cell carcinoma of the uterine cervix
2. International Federation of Gynecology and Obstetrics (FIGO) Stage IIB(>= 4 cm in diameter), III, or IVA disease
3. No para-aortic lymph nodes >= 1 cm in minimum diameter on CT images
4. The tumor had to be grossly measurable.
5. Age between 20 and 70 years
6. Performance status 0 - 2
7. Patients with no histories of prior chemotherapy or pelvic radiotherapy for cervical cancer
8. Normal organ function
(WBC >= 3000/mm3,Hb >= 10g/dl, Plt>= 100,000/mm3, T-Bil.<= 1.5mg/dl, AST(GOT) and ALT(GPT) <= 100IU/dl, Cre <= 1.5mg/dl, CCR >= 50ml/min, ECG normal or require no treatment
9. Estimated life expectancy of _6 months
10. Written informed consent
1. Severe complicating illness
2. Active double cancer
3. Rectal invasion
4. History of pelvic radiotherapy
5. History of prior chemotherapy
6. medical, psychological or others reason that primary doctor think ineligible
20
1st name | Masaru |
Middle name | |
Last name | Wakatsuki |
National Institute for Quantum and Radiological Science and Technology
QST Hospital
263-8555
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
043-206-3306
wakkun100@yahoo.co.jp
1st name | Masaru |
Middle name | |
Last name | Wakatsuki |
National Institute for Quantum and Radiological Science and Technology
QST Hospital
263-8555
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
043-206-3306
http://www.nirs.go.jp/hospital/index.shtml
wakkun100@yahoo.co.jp
National Institute for Quantum and Radiological Science and Technology
National Institute for Quantum and Radiological Science and Technology
Other
National Institute for Quantum and Radiological Science and Technology
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
043-206-3193
genkoba@nirs.go.jp
NO
放射線医学総合研究所(千葉県)
2013 | Year | 10 | Month | 17 | Day |
Unpublished
4
Terminated
2013 | Year | 05 | Month | 20 | Day |
2012 | Year | 05 | Month | 23 | Day |
2012 | Year | 06 | Month | 06 | Day |
2016 | Year | 03 | Month | 31 | Day |
2013 | Year | 10 | Month | 15 | Day |
2021 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012837
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