UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032949
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

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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

Obstetrics 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 or person

Institute

Japanese Gynecologic Oncology Group

Institute

Department

Personal name



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

540

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Results cannot be published due to analysis delay

Date of the first journal publication of results

2023 Year 03 Month 31 Day

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

2018 Year 05 Month 08 Day

Anticipated trial start date

2018 Year 05 Month 22 Day

Last follow-up date

2020 Year 03 Month 31 Day

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

2021 Year 06 Month 14 Day



Link to view the page

Value
https://center6.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