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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003864
Receipt No. 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

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Basic information
Public title Concurrent radiotherapy with cisplatin and etoposide for small cell neuroendocrine carcinoma of the cervix
Acronym EP-CCRT for SCNEC
Scientific Title Concurrent radiotherapy with cisplatin and etoposide for small cell neuroendocrine carcinoma of the cervix
Scientific Title:Acronym EP-CCRT for SCNEC
Region
Japan

Condition
Condition small cell neuroendocrine carcinoma of the cervix
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Adverse event
Feasibility
Key secondary outcomes Two-year cumulative survival rate
Progression-free survival
Response rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 CCRT
CDDP
Etoposide
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
70 years-old >=
Gender Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hirokazu
Middle name
Last name Usui
Organization Graduate School of Medicine, Chiba University
Division name Department of Reproductive Medicine
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Email hirokazu-usui@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Hirokazu
Middle name
Last name Usui
Organization Chiba University Hospital
Division name Department of Gynecology
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
TEL 043-222-7171
Homepage URL
Email hirokazu-usui@faculty.chiba-u.jp

Sponsor
Institute Department of Gynecology, Chiba University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Center, Chiba University Hospital
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
Tel +81-43-222-7171
Email ccrc1@mac.com

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 千葉大学医学部附属病院(婦人科)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 05 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000004615
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000004615
Number of participants that the trial has enrolled 9
Results
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.
Results date posted
2019 Year 03 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
Nine patients were enrolled and finished the protocol. 
Adverse events
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.
Outcome measures
(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). 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 02 Month 16 Day
Date of IRB
2010 Year 04 Month 09 Day
Anticipated trial start date
2010 Year 12 Month 06 Day
Last follow-up date
2017 Year 10 Month 28 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 03 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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