UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000076
Receipt number R000000125
Scientific Title A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.
Date of disclosure of the study information 2010/04/01
Last modified on 2005/08/24 15:54:12

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Basic information

Public title

A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.

Acronym

Postoperative radiotherapy for cervical cancer.

Scientific Title

A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.

Scientific Title:Acronym

Postoperative radiotherapy for cervical cancer.

Region

Japan


Condition

Condition

Patients who had radical hysterectomy for stage IB-IIB cervical cancer, and were certified to have lymph node mestastases histologocally after radical surgery. Patients with only squamous cell carcinoma were eligible.

Classification by specialty

Obstetrics and Gynecology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the efficiency of concurrent chemoradiotherapy (group A) and chemotherapy (Group B) for paitents with lymph node metastases from cervical cancer. Patients are randomized to group A or B after radical surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Recurrent rata including distant metastases.

Key secondary outcomes

Late adverse effect
Survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Concurrent chemoradiotherapy (Group A)
Whole pelvic irradiation (50 Gy) and
CDDP 70mg/m2, each 4 week, 3 times.

Interventions/Control_2

Chemotherapy (Group B)
CDDP 70mg/m2, each 4 week, 3 times.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. squamous cell carcinoma of the cervix and clinical stage IB-IIB.
2. radical hysterectomy was performed.
3. with histologically certified lymph node metastases.
4. no abnormal findings in laboratory tests.
5. PS is between 0-2.
6. Age is between 20-75.
7. No chemotherapy for other cancer (except cervical cancer) within recent 3 months.

Key exclusion criteria

1. Past history of pelvic surgery (except appendectomy).
2. past history of pelvic irradiation.
3. Positive surgical margin, or positive paraaortic lymph nodes.
4. Estimaated survival is less than 6 months.
5. Renal dysfunction.
6. Acitve infection (Tuberculosis or mycosis) in the pelvis.
7. Active double cancer.
8. Otehr reasons that is not eligible to this trial.

Target sample size

170


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Ito, M.D.

Organization

Chiba University, Graduate School of Medicine,

Division name

Department of Radiology

Zip code


Address

1-8-1 Inohana, Chuoku, Chiba City, 260-8670, Japan

TEL

043-226-2099

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takahsi Uno, M.D.

Organization

Chiba University, Graduate School of Medicine,

Division name

Department of Radiology

Zip code


Address

1-8-1 Inohana, Chuoku, Chiba City, 260-8670, Japan

TEL

043-226-2100

Homepage URL


Email

unotakas@faculty.chiba-u.jp


Sponsor or person

Institute

Study Group of Postoperative radiotherapy for cervical cancer.

Institute

Department

Personal name



Funding Source

Organization

Grant of Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Date of protocol fixation

2005 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2005 Year 02 Month 01 Day

Last follow-up date

2010 Year 04 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2012 Year 04 Month 01 Day

Date analysis concluded

2012 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 24 Day

Last modified on

2005 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000125


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name