Unique ID issued by UMIN | UMIN000003864 |
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Receipt number | R000004615 |
Scientific Title | Concurrent radiotherapy with cisplatin and etoposide for small cell neuroendocrine carcinoma of the cervix |
Date of disclosure of the study information | 2010/07/05 |
Last modified on | 2019/03/22 20:56:48 |
Concurrent radiotherapy with cisplatin and etoposide for small cell neuroendocrine carcinoma of the cervix
EP-CCRT for SCNEC
Concurrent radiotherapy with cisplatin and etoposide for small cell neuroendocrine carcinoma of the cervix
EP-CCRT for SCNEC
Japan |
small cell neuroendocrine carcinoma of the cervix
Obstetrics and Gynecology |
Malignancy
NO
The purpose of this study is to confirm safety and feasibility of concurrent radiotherapy with cisplatin and etoposide for small cell neuroendocrine carcinoma of the cervix.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Adverse event
Feasibility
Two-year cumulative survival rate
Progression-free survival
Response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
CCRT
CDDP
Etoposide
20 | years-old | <= |
70 | years-old | >= |
Female
1) Pathologically confirmed neuroendocrine tumors of uterine cervix, stage IB - IVA
2) No prior treatment
3) Age from 20 to 70
4) ECOG PS 0-1
5)Normal organ function
WBC >= 3000/mm3
neutrophils >= 1,500/mm3
platelets >= 100,000/mm3
total Bilirubin =<1.5mg/dl
BUN =<25mg/dl
serum creatinine =<1.2 mg/dl
Normal E.C.G
6)No hypersensitivity for CDDP and Etoposide
7)Written informed consent
1) Patients with severe ischemic heart disease or arrhythmia.
2) Patients with history of myocardial within 6 months
3) Patients with liver cirrhosis
4) Patients with repeat bowel fresh bleeding
5) Patients mental disorder
6) Patients with uncontrollable diabetes
7) Patients with bowel obstruction
8) Patients with active other malignancy
9) Patients which a physician in charge judged not to be eligible
15
1st name | Hirokazu |
Middle name | |
Last name | Usui |
Graduate School of Medicine, Chiba University
Department of Reproductive Medicine
260-8677
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
043-222-7171
hirokazu-usui@faculty.chiba-u.jp
1st name | Hirokazu |
Middle name | |
Last name | Usui |
Chiba University Hospital
Department of Gynecology
260-8677
1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
043-222-7171
hirokazu-usui@faculty.chiba-u.jp
Department of Gynecology, Chiba University Hospital
none
Self funding
Clinical Research Center, Chiba University Hospital
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
+81-43-222-7171
ccrc1@mac.com
NO
千葉大学医学部附属病院(婦人科)
2010 | Year | 07 | Month | 05 | Day |
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000004615
Unpublished
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000004615
9
In 5 of 9 patients, daily cisplatin and etoposide could be delivered continuously as planned without any modification. In the other patients, administration of cisplatin and etoposide had to be interrupted for 5 days (5th week). All patients developed grade 2 or worse leukopenia including after treatment, G2 in two, G3 in four, and G4 in three. G4 neutropenia was observed in two patients. G2 or worse anemia was observed in 5. One patient had G3 nonhematologic toxicities, diarrhea.
2019 | Year | 03 | Month | 22 | Day |
Median age (range) of participants were 53.8 (27.2-66.4) years. Clinical stages were 4 1B1, 2 1B2, 2 2B, and 1 3B. Performance status were 6 PS0 and 3 PS1.
Nine patients were enrolled and finished the protocol.
All patients developed grade 2 or worse leukopenia including after treatment, grade 2 in two, grade 3 in four, and grade 4 in three. Grade 4 neutropenia was observed in two patients. Grade 2 or worse anemia was observed in 5. One patient had grade 3 nonhematologic toxicities, diarrhea.
(Primary endpoints)
The completed rates of radiation and concurrent chemotherapy were one hundred percent.
Adverse events: 3 grade 4 leukopenia and 2 grade 4 neutropenia were observed. One patient had grade 3 non-hematologic toxicities, diarrhea.
(Secondary endpoints)
The rate of 2-years survival was 78% (7/9).
The median of progression free survival was 37.8 (4.9-89.5) months.
The response rate was 89% (8/9).
Completed
2010 | Year | 02 | Month | 16 | Day |
2010 | Year | 04 | Month | 09 | Day |
2010 | Year | 12 | Month | 06 | Day |
2017 | Year | 10 | Month | 28 | Day |
2022 | Year | 12 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2010 | Year | 07 | Month | 03 | Day |
2019 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004615
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