UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of postoperative IMRT (intensity modulated radiotherapy) for cervical cancer with high risk factors for relapse.
Title of the study (Brief title)	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	Obsterics 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	Jun Itami
Organization	National Cancer Center Hospital, Tokyo, Japan.
Division name	Department of Radiation Oncology
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo 104-0054 Japan
TEL
Email

Public contact
Name of contact person
Organization	National Cancer Center Hospital, Tokyo, Japan.
Division name	Department of Radiation Oncology
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo 104-0054 Japan
TEL
Homepage URL
Email

Sponsor
Institute	National Cancer Center Hospital, Tokyo, Japan.
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010650