UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009078 |
|---|---|
| Receipt number | R000010650 |
| Scientific Title | Clinical trial of postoperative IMRT (intensity modulated radiotherapy) for cervical cancer with high risk factors for relapse. |
| Date of disclosure of the study information | 2012/10/10 |
| Last modified on | 2018/03/07 09:00:30 |
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Basic information
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
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
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
Public contact
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
Sponsor or person
Institute
National Cancer Center Hospital, Tokyo, Japan.
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
Address
Tel
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
| 2012 | Year | 10 | Month | 10 | 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
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
Other related information
Management 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
