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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032949
Receipt No. R000037317
Scientific Title A retrospective analysis of the indication of extended-field irradiation for cervical cancer patients who had previously undergone concurrent chemoradiotherapy
Date of disclosure of the study information 2018/06/15
Last modified on 2019/06/12

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Basic information
Public title A retrospective analysis of the indication of extended-field irradiation for cervical cancer patients who had previously undergone concurrent chemoradiotherapy
Acronym Analysis on adaptation of prophylactic expansion irradiation in cervical cancer with CCRT
Scientific Title A retrospective analysis of the indication of extended-field irradiation for cervical cancer patients who had previously undergone concurrent chemoradiotherapy
Scientific Title:Acronym Analysis on adaptation of prophylactic expansion irradiation in cervical cancer with CCRT
Region
Japan

Condition
Condition cervical carcinoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For cervical cancer cases in which CCRT was performed, we will consider adaptation of prophylactic expansion irradiation in images before treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Pathological tissue subtype, age, FIGO advanced stage, TNM classification
2. Initial treatment (CCRT) start date, treatment end date, treatment details (dose, irradiation method, chemotherapy drug (limited to platinum single agent) and dose), paraaortic lymph node (PAN) biopsy
3. Status of residual disease / recurrence, date of diagnosis of recurrence / relapse, site of recurrence (pelvic, distant, pelvic LN, paraaortic LN)
4. Last confirmed date of survival, day of death
b. Radiation therapy: CCRT (irradiation field, irradiation method, Linac, electron beam, total dose)
c. Chemotherapy: type of regimen, number of cycles
d. Imaging evaluation
1. Size of tumor (diameter, volume) (assessed using MRI)
2. ADC value of tumor
3. Tumor growth type (intramural, extramural) (MRI)
4. Presence or absence of uterine corpus invasion (MRI)
5. Degree of interstitial infiltration (1/2 or more or less) (MRI)
6. Presence or absence of cervical parametrial invasion (MRI)
7. Presence or absence of lymph node metastasis, position and number of enlarged lymph nodes according to CT, MR, or PET scans
8. SUV max of tumor according to PET
9. Presence and presence of other metastases
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 (1) Patients diagnosed with cervical cancer from January 2009 to December 2014 who had undergone CCRT using platinum single agent.
(2) Metastatic cervical cancer was excluded.
(3).FIGO stage IB1 to IVA were included..
(4) All cases of squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma were included.
(5) Pelvic MRI (T1, T2, DWI) was performed before CCRT, as well as enhanced CT (if possible PET) for comprehensive review from the chest to lower abdomen (PET-CT, PET-MR if possible)
(6) Minimum requirements for imaging studies were, CT: number of detectors (more than 64 rows), enhanced CT (with or without dynamic contrast-enhanced imaging), MRI: magnetic field of1.5 T or more, diffusion weighted image required.
Key exclusion criteria Metastatic cervical cancer
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Tozawa
Organization St. Marianna University School of Medicine
Division name Obstetrics and Gynecology
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, JAPAN
TEL 0449778111
Email a2ono@marianna-u.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Tozawa
Organization St. Marianna University School of Medicine
Division name Obstetrics and Gynecology
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, JAPAN
TEL 0449778111
Homepage URL http://www.jgog.gr.jp/index.html
Email a2ono@marianna-u.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group
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 Division of Graduate Student Affairs and Research Promotion
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, JAPAN
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.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
2018 Year 06 Month 15 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information Retrospective observation study
All cases in which curative CCRT was implemented from January 2009 - December 2014 at the JGOG participating facility will be subject to registration.
Registration starts after each facility gained approval from the respective ethics review committee (IRB). A copy of the IRB approval letter to the research secretariat by e-mail or post office. After that, a person-in-charge at the research collaborating facility will conduct medical examination survey using the survey form provided.

Management information
Registered date
2018 Year 06 Month 11 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037317

Research Plan
Registered date File name
2018/08/01 実施計画書 ZKCCRT画像調査研究 20180525v1.2.docx

Research case data specifications
Registered date File name
2018/08/01 JGOG1083S_臨床CRF 20180608改訂版.xlsx

Research case data
Registered date File name


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