UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052234 |
|---|---|
| Receipt number | R000059247 |
| Scientific Title | Multi-institutional retrospective study on chemotherapy and pelvic radiotherapy for stage IVB cervical cancer. |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/03/26 15:56:48 |
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Basic information
Public title
Multi-institutional retrospective study on chemotherapy and pelvic radiotherapy for stage IVB cervical cancer.
Acronym
JGOG1088S/JROSG22-1
Scientific Title
Multi-institutional retrospective study on chemotherapy and pelvic radiotherapy for stage IVB cervical cancer.
Scientific Title:Acronym
JGOG1088S/JROSG22-1
Region
| Japan |
Condition
Condition
Stage IVB cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the results of treatment with and without additional pelvic radiotherapy in patients with stage IVB cervical cancer treated with chemotherapy in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival, rate of urinary tract and gastrointestinal tract adverse events (CTCAE Ver 5.0 Grade 3 or higher), rate of genital bleeding requiring blood transfusion
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Eighteen years of age or older at the time of initial examination.
2) Patients who has a histopathological diagnosis of cervical cancer and the histological type is either squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
3) Patients diagnosed with stage IVB (FIGO2018, Nissanpu 2020) at first presentation. Cases in which distant metastasis is limited to inguinal lymph node metastasis are excluded.
4) Patients who received chemotherapy with a treatment start date between January 1, 2016 and December 31, 2020.
Chemotherapy in this section must have been administered as either (1) or (2) below. Radiotherapy is not required.
(1) Patients must have received at least 4 courses of platinum doublet. (Bevacizumab is not required.)
(2) Concurrent chemoradiotherapy with platinum drugs was administered.
Key exclusion criteria
1) Patients who refused data registration.
2) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
3) Patients who received surgery on the primary tumor during the course of treatment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Tsuchida |
Organization
Kanagawa Cancer Center
Division name
Department of Radiation Oncology
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama City, Kanagawa 241-8515, Japan
TEL
045-520-2222
ketsuchi@kcch.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Tsuchida |
Organization
Kanagawa Cancer Center
Division name
Department of Radiation Oncology
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama City, Kanagawa 241-8515, Japan
TEL
045-520-2222
Homepage URL
ketsuchi@kcch.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group (JGOG)
Japanese Radiation Oncology Study Group (JROSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama City, Kanagawa 241-8515, Japan
Tel
045-520-2222
clinical_trials@kcch.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
| 2023 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2023 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059247
