UMIN-ICDS Clinical Trial

Public title

A Prospective Observational Study of Advanced Radiation Therapy for Locally Advanced Cervical Cancer in FNCA Member Countries

Acronym

Cervix-VI Study

Scientific Title

Prospective observational study of Intensity Modulated Radiation Therapy and 3D-Image-guided brachytherapy for Locally Advanced Cervical Cancer in FNCA member countries (Cervix-VI)

Scientific Title:Acronym

FNCA Cervix-VI Study

Region

Japan

Asia(except Japan)

Condition

Uterine cervical cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the safety and efficacy of combination of intensity-modulated radiotherapy (IMRT) and 3D-image-guided brachytherapy (3D-IGBT) for patients with locally advanced cervical cancer in FNCA countries.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of acute gastrointestinal toxicity (Grade 2 or worse)

Key secondary outcomes

2-year overall survival rate, local control rate, progression-free survival rate, acute and late toxicities rates (other than acute gastrointestinal toxicity)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Female

Key inclusion criteria

1. Squamous cell carcinoma of the uterine cervix
2. FIGO 2018 stage IIB-IIIC1r, excluding stage IIIA
3. Age: 20-70 years
4. WHO performance status (PS): 0-2
5. No prior chemotherapy, pelvic radiotherapy, or pelvic surgery
6. Life expectancy >=6 months
7. Adequate bone marrow, hepatic, and renal function:
- WBC >=3000/uL
- Hb >=9 g/dL
- Platelet count >=100000/mm3
- Total bilirubin <=1.5 mg/dL (<=25.65 umol/L)
- AST/ALT <=2 x upper limit of normal
- Serum creatinine <=1.5 mg/dL (<=132.6 umol/L)
8. Written informed consent
9. Pretreatment imaging:
- CT of the abdomen and pelvis (mandatory)
- MRI of the pelvis (recommended)
10. No para-aortic lymph node (PALN) metastasis on CT (short-axis diameter >1 cm)
11. Not pregnant or breastfeeding

Key exclusion criteria

1. Presence of severe concomitant illness
2. History of other malignancies within the past 5 years except basal cell carcinoma or squamous cell carcinoma in-situ of the skin
3. Tumor involving the lower 1/3 of the vagina (IIIA disease)

Target sample size

160

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Ohno

Organization

Gunma University Hospital

Division name

Department of Radiation Oncology

Zip code

371-8511

Address

3-39-15 Showa-cho, Maebashi City, Gunma Prefecture

TEL

027-220-8383

Email

tohno@gunma-u.ac.jp

Name of contact person

1st name	Kento
Middle name
Last name	Tomizawa

Organization

Gunma University Hospital

Division name

Heavy Ion Medical Center

Zip code

371-8511

Address

3-39-22 Showa-machi, Maebashi, Gunma, Japan

TEL

027-220-8391

Homepage URL

Email

k-tomizawa@gunma-u.ac.jp

Institute

Gunma University

Institute

Department

Personal name

Organization

National Institutes for Quantum Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University Hospital Clinical Research Review Board

Address

3-39-15 Showamachi, Maebashi, Gunma, Japan

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

15

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

2026

Year

06

Month

09

Day

Date of IRB

2026

Year

06

Month

09

Day

Anticipated trial start date

2026

Year

06

Month

09

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a prospective observational study designed to collect data on treatment outcomes and adverse events in patients undergoing definitive chemoradiotherapy for cervical cancer as part of standard clinical practice. Definitive chemoradiotherapy will be administered in accordance with internationally established standards, consisting of a combination of external beam radiotherapy and brachytherapy. Detailed information regarding the recommended examinations, treatments, and follow-up procedures in this study is provided in a separate document. As this study is observational in nature, no additional interventions beyond standard clinical care will be mandated. Adverse events are anticipated to be within the range expected in routine clinical practice, and their occurrence will be systematically collected as part of clinical data.

Registered date

2026

Year

07

Month

28

Day

Last modified on

2026

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071306