Unique ID issued by UMIN | UMIN000032949 |
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Receipt number | 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 | 2021/06/14 11:32:19 |
A retrospective analysis of the indication of extended-field irradiation for cervical cancer patients who had previously undergone concurrent chemoradiotherapy
Analysis on adaptation of prophylactic expansion irradiation in cervical cancer with CCRT
A retrospective analysis of the indication of extended-field irradiation for cervical cancer patients who had previously undergone concurrent chemoradiotherapy
Analysis on adaptation of prophylactic expansion irradiation in cervical cancer with CCRT
Japan |
cervical carcinoma
Obstetrics and Gynecology |
Malignancy
NO
For cervical cancer cases in which CCRT was performed, we will consider adaptation of prophylactic expansion irradiation in images before treatment
Efficacy
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
Observational
Not applicable |
Not applicable |
Female
(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.
Metastatic cervical cancer
600
1st name | Akiko |
Middle name | |
Last name | Tozawa |
St. Marianna University School of Medicine
Obstetrics and Gynecology
216-8511
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, JAPAN
0449778111
a2ono@marianna-u.ac.jp
1st name | Akiko |
Middle name | |
Last name | Tozawa |
St. Marianna University School of Medicine
Obstetrics and Gynecology
216-8511
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, JAPAN
0449778111
http://www.jgog.gr.jp/index.html
a2ono@marianna-u.ac.jp
Japanese Gynecologic Oncology Group
Japanese Gynecologic Oncology Group
Other
Division of Graduate Student Affairs and Research Promotion
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, JAPAN
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
NO
2018 | Year | 06 | Month | 15 | Day |
Unpublished
540
Delay expected |
Results cannot be published due to analysis delay
2023 | Year | 03 | Month | 31 | Day |
Enrolling by invitation
2018 | Year | 05 | Month | 08 | Day |
2018 | Year | 05 | Month | 08 | Day |
2018 | Year | 05 | Month | 22 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
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.
2018 | Year | 06 | Month | 11 | Day |
2021 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037317
Research Plan | |
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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 | |
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Registered date | File name |
2018/08/01 | JGOG1083S_臨床CRF 20180608改訂版.xlsx |
Research case data | |
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Registered date | File name |