UMIN-CTR Clinical Trial

Public title

Clinical trial of postoperative IMRT (intensity modulated radiotherapy) for cervical cancer with high risk factors for relapse.

Acronym

Clinical trial of postoperative IMRT (intensity modulated radiotherapy) for cervical cancer with high risk factors for relapse.

Scientific Title

Clinical trial of postoperative IMRT (intensity modulated radiotherapy) for cervical cancer with high risk factors for relapse.

Scientific Title:Acronym

Clinical trial of postoperative IMRT (intensity modulated radiotherapy) for cervical cancer with high risk factors for relapse.

Region

Japan

Condition

Postoperative cervical cancer patients with high risk factors for relapse

Classification by specialty

Obstetrics and Gynecology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To estimate safety of IMRT for postoperative cervical cancer patients with high risk factors for relapse

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Incidence and severity of acute adverse events

Key secondary outcomes

In-pelvis progression free survival
Progression free survival
Overall survival
Incidence and severity of chronic adverse events
Percentage of accomplishment of treatment

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intensity modulated radiotherapy(IMRT)
50Gy/25fr

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Female

Key inclusion criteria

1)Histologically confirmed squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma of cervix.
2)underwent radical hysterectomy and pelvic lymphadenectomy.
3)Histologically confirmed parametrium invasion or pelvic lymph node metastasis.
4) Age between 20 and 75 years at registration.
5) Performance status(ECOG) 0-2.
6)No history of radiotherapy or chemotherapy for abdominal region.
7)Not planned to use concurrent chemotherapy during radiotherapy.
8)Sufficient bone marrow functions should be confirmed by the clinical tests within 28 days before registration as follows:
i)WBC:>=2,000/mm3
ii)neutrophil:>=1,500/mm3
iii)hemoglobin:>=8.0g/dL
iv)blood platelet:>=100,000mm3
9)Written consent obtained.

Key exclusion criteria

1) Patients with DM using continuous insulin or DM of poor control.
2) Patients with hypertension of poor control.
3) Patients with unstable angina or with myocardial infarction last 6 months.
4) Patients with active concomitant malignancy.
5) Patients with active infection requiring systemic therapy.
6) Pelvic infection of more than grade 3.
7) Patients with fever more than 38.0 degrees C at the registration.
8) Patients with psychological problems and inappropriate for entering this study.
9) Patients with ulcerative colitis or Crohn disease.
10) Patients with collagen disease such as SLE or scleroderma.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Jun Itami

Organization

National Cancer Center Hospital, Tokyo, Japan.

Division name

Department of Radiation Oncology

Zip code

Address

5-1-1,Tsukiji,Chuo-ku,Tokyo 104-0054 Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

National Cancer Center Hospital, Tokyo, Japan.

Division name

Department of Radiation Oncology

Zip code

Address

5-1-1,Tsukiji,Chuo-ku,Tokyo 104-0054 Japan

TEL

Homepage URL

Email

Institute

National Cancer Center Hospital, Tokyo, Japan.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

10

Month

02

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

10

Day

Last follow-up date

2017

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

10

Day

Last modified on

2018

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010650