UMIN-CTR Clinical Trial

Public title

Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)

Acronym

Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)

Scientific Title

Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)

Scientific Title:Acronym

Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)

Region

Japan

Condition

Postoperative uterine cervical cancer patients with high-risk prognostic factors

Classification by specialty

Obstetrics and Gynecology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To demonstrate the effecacy and safety of treatment with intensity modulated radiation therapy and weekly 40mg/m2 cisplatin on postoperative uterine cervical cancer patients with high-risk prognostic factors.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

3-year relapse free survival

Key secondary outcomes

Overall survival, locoregional-relapse free survival, proportion of >= Grade 3 lower gastrointestinal complication, proportion of lower limb edema, adverse events, serious adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver

Interventions/Control_1

Cisplatin (40 mg/m2) is administered intravenously on a
weekly basis for 5 weeks during the course of IMRT. The IMRT dose is 50.4 Gy/28 fr.

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

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Female

Key inclusion criteria

1. Clinical stage IB1, IB2, IIA1, IIA2, IIB cervical cancer (FIGO 2008)
2. Histological findings of squamous cell carcinoma (keratinizing or non-keratinizing), adenocarcinoma (endocervical mucinous type, intestinal mucinous type or endometrial type), or adenosquamous carcinoma
3. Histologically confirmed positive pelvic lymph nodes and/or parametrial invasion.
4. No distant metastasis in chest to pelvic contrast enhanced CT within 56 days before surgery
5. In case with node dissection except pelvic lesion, there is no positive node in these lesions.
6. Radical hysterectomy is performed and the following (i) to (v) are fulfilled.
i) R0 resection
ii) Negative margin is confirmed by pathological findings.
iii) At least 20 lymph nodes dissection confirmed by pathological findings.
iv) Ligamentum cardinale is removed.
v) The cut length of paracolpium and vagina is 2cm or more.
7. Aged 20 to 70 years old
8. ECOG performance status of 0 or 1
9. Within 28 to 56 days after surgery
10. No following prior treatment
i) Surgery except for cervical conization or radical hysterectomy for uterine cervical cancer
ii) Surgery for lower abdominal or pelvic malignancy
iii) Radiation therapy or chemotherapy for other malignancies
11. Adequate organ functions
12. Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor.
2) Active systemic infections to be treated.
3) Body temperature of 38 or more degrees Celsius
4) Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding
5) Severe psychiatric disease
6) Continuous systemic steroid treatment
7) Insulin-dependent or uncontrolled diabetes mellitus
8) Uncontrolled hypertension
9) Unstable angina, or history of myocardial infarction within 6 months
10) HBs antigen or HCV antibody positive
11) HIV antibody positive
12) Interstitial pneumonitis, lung fibrosis or severe emphysema on chest CT

Target sample size

220

Name of lead principal investigator

1st name
Middle name
Last name	Takafumi Toita

Organization

Okinawa Prefectural Chubu Hospital

Division name

Department of Radiology

Zip code

Address

Miyazato 281 Uruma, Okinawa, 904-2293, Japan

TEL

098-973-4111ext3920

Email

b983255@med.u-ryukyu.ac.jp

Name of contact person

1st name
Middle name
Last name	Fumiaki Isohashi

Organization

JCOG1402 Coordinating Office

Division name

Osaka University Graduate School of Medicine

Zip code

Address

2-2(D10) Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3482

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）
札幌医科大学（北海道）
岩手医科大学（岩手県）
東北大学病院（宮城県）
筑波大学医学医療系（茨城県）
茨城県立中央病院・茨城県地域がんセンター（茨城県）
群馬大学医学部附属病院（群馬県）
群馬県立がんセンター（群馬県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学総合医療センター（埼玉県）
千葉県がんセンター（千葉県）
千葉大学医学部（千葉県）
東京慈恵会医科大学附属柏病院（千葉県）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
慶應義塾大学病院（東京都）
昭和大学病院（東京都）
がん研究会有明病院（東京都）
東京大学医学部（東京都）
東京慈恵会医科大学附属病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
NTT東日本関東病院（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
信州大学医学部（長野県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
名古屋大学医学部（愛知県）
京都大学医学部附属病院（京都府）
京都府立医科大学（京都府）
大阪大学医学部（大阪府）
近畿大学医学部（大阪府）
大阪国際がんセンター（大阪府）
大阪市立総合医療センター（大阪府）
大阪医科大学（大阪府）
神戸市立医療センター中央市民病院（兵庫県）
兵庫県立がんセンター（兵庫県）
鳥取大学医学部（鳥取県）
国立病院機構呉医療センター・中国がんセンター（広島県）
国立病院機構四国がんセンター（愛媛県）
愛媛大学医学部附属病院（愛媛県）
九州大学病院（福岡県）
国立病院機構九州がんセンター（福岡県）
熊本大学医学部（熊本県）
鹿児島大学病院（鹿児島県）
鹿児島市立病院（鹿児島県）
琉球大学医学部附属病院（沖縄県）

Date of disclosure of the study information

2017

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

01

Month

31

Day

Date of IRB

Anticipated trial start date

2017

Year

04

Month

17

Day

Last follow-up date

2026

Year

10

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

04

Month

17

Day

Last modified on

2018

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030672