UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003864
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

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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

Obstetrics 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 or person

Institute

Department of Gynecology, Chiba University Hospital

Institute

Department

Personal name



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

Value
https://center6.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