UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025274 |
|---|---|
| Receipt number | R000029072 |
| Scientific Title | A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer. |
| Date of disclosure of the study information | 2016/12/14 |
| Last modified on | 2026/06/22 14:09:58 |
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Basic information
Public title
A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer.
Acronym
A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT)
Scientific Title
A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer.
Scientific Title:Acronym
A retrospective study of late effect and prognosis of concurrent chemoradiotherapy (CCRT)
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clear the late effect of CCRT for locally advanced cervical cancer
Basic objectives2
Others
Basic objectives -Others
To clear the prognosis of CCRT for locally advanced cervical cancer
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of small intestinal obstruction, rectal hemmorrhage, and bladder hemmorrhage
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cervical cancer Stage IB2, IIB, IIIB, and IVA and treated by CCRT.
Treatment start is from January 2001 to December 2010.
Key exclusion criteria
CCRT for post operative treatment
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kurosaki |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gynecologic Oncology
Zip code
3501298
Address
Yamane 1397-1, Hidaka city, Saitama, Japan
TEL
042-984-4111
akirak@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kurosaki |
Organization
GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto)
Division name
Department of Gynecologic Oncology
Zip code
3501298
Address
Morohongo 5, Moroyama town, Saitama, Japan
TEL
049-292-9043
Homepage URL
akirak@saitama-med.ac.jp
Sponsor or person
Institute
GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto)
Institute
Department
Personal name
Funding Source
Organization
GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical university International Medical center, IRB
Address
Yamane 1397-1, Hidaka city, Saitama, Japan
Tel
0429844111
chikens@saitama-med.ac.jp
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
| 2016 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
doi.org/10.24689/sms.52.2_55
Publication of results
Published
Result
URL related to results and publications
doi.org/10.24689/sms.52.2_55
Number of participants that the trial has enrolled
304
Results
The study included a total of 304 patients. The median follow-up period for all patients was 79.3 months (range: 1.2-162.9 months). Grade 3 or higher late toxicity occurred in 32 patients (10.5%). The 5 year cumulative incidence rates of grade 3 or higher late toxicity in the small intestine, rectum, and bladder were 3.7% (95% confidence interval 1.9%-7.1%), 3.8% (95% confidence interval 2.1%-7.0%), and 3.2% (95% confidence interval 1.5%-6.7%), respectively.
Results date posted
| 2026 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cervical cancer patients with Stage IB2 to IVA diagnosed at a Gynecologic Oncology Clinical Trials Consortium (GOTIC) participating site between 2001 and 2010 and who received concurrent chemoradiotherapy (CCRT).
Participant flow
retrospective study
Adverse events
retrospective study
Outcome measures
age, height, body weight, performance status at treatment initiation, presence of diabetes mellitus, major comorbidities, clinical stage, histological type, primary tumor size, and sites of enlarged lymph nodes. For radiation-related factors, we collected data on EBRT start and end dates, EBRT method and dose, ICBT start and end dates, and ICBT total dose. For chemotherapy-related factors, we recorded treatment dates, regimen, total dose, and number of cycles. Late toxicities were defined as symptoms developing over 60 days after CCRT completion. The variables and severity of symptoms were categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each late toxicity, the onset date, treatment, and outcome were recorded. Five year cumulative rates were used to report the incidence of late toxicities. Prognostic data included recurrence status, site and date of recurrence, final survival confirmation date, and cause of death, if applicable.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter retrospective study
Management information
Registered date
| 2016 | Year | 12 | Month | 14 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029072
