UMIN-CTR Clinical Trial

Public title

A phase II clinical trial of Carbon-ion radiotherapy for patients with locally advanced adenocarcinoma of the uterine cervix

Acronym

Carbon-ion radiotherapy for locally advenced adenocarcinoma of the uterine cervix (iROCK-1704GYN)

Scientific Title

A phase II clinical trial of Carbon-ion radiotherapy for patients with locally advanced adenocarcinoma of the uterine cervix

Scientific Title:Acronym

Carbon-ion radiotherapy for locally advenced adenocarcinoma of the uterine cervix (iROCK-1704GYN)

Region

Japan

Condition

Locally advanced adenocarcinoma of the uterine

Classification by specialty

Obstetrics and Gynecology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of carbon-ion radiotherapy for the patients with locally advanced adenocarcinoma of the uterine

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Relapse free survival at 3 years

Key secondary outcomes

1) Local control survival
2) Local response rate
3) Adverse event rate
4) Overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

1) Carbon-ion Radiotherapy;
3.0Gy (RBE) per day, A dose of 36.0Gy (RBE) / 12 fractions
4.8Gy (RBE) per day, A dose of 38.4Gy (RBE) / 8 fractions
A total dose of 74.4Gy (RBE) / 20 fractions

2) Carbon-ion Radiotherapy intracavitary irradiation combination
Carbon-ion Radiotherapy;
3.0Gy (RBE) per day, A dose of 36.0Gy (RBE) / 12 fractions
4.8Gy (RBE) per day, A dose of 38.4Gy (RBE) / 4 fractions
A total dose of 55.2Gy (RBE) / 16 fractions
Intracavitary irradiation;
5.5Gy per day, A total dose of 16.5Gy (EQD2; 21.3Gy10) / 3 fractions

Chemotherapy;
cisplatin (40mg / m2 / week) for 5 weeks

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

Not applicable

Gender

Female

Key inclusion criteria

In common with carbon-ion radiotherapy simultaneous combination arm and the Carbon-ion radiotherapy single arm, all the following items shall be satisfied

1) Diagnosed as adeno-squamous cell carcinoma or adenocarcinoma of uterine cervix by cytology or histpathology
2) International Federation of Gynecology and Obstetrics (FIGO, 2008) stage IIB, III, IVA disease
3) No para-aortic lymph nodes >= within 4 weeks before registration 1 cm in minimum diameter on CT images
4) Without obvious organ metastasis by diagnostic imaging
5) Aged 20 or above at the time of registration
6) 0 to 2 of performance status (ECOG)
7) Patients with unresectable cases due to lesion status, age, complications or deny the resection
8) Patients who has no pretreatment history of chemical therapy and operation for cervical cancer
9) Patients who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B)
10) Written consent obtained for the participation in this study

In addition to the above criteria, the following conditions are all satisfied for the arm to be used simultaneously with carbon-ion irradiation chemotherapy simultaneous combination. All the laboratory date are measured within 8 days before trial registration

1) Aged 75 or less at the time of registration
2) White blood cells >= 3,500 /mm3
3) Hemoglobin >= 9.0 g/dl
4) Platelet >= 100,000 /mm3
5) Albumin >= 3.0 g/dl
6) Total bilirubin =< 2 mg/dl
7) GOT(AST) =< 100 IU
8) Serum creatinine =< 1.5 mg/dl
9) Creatinine clearance >= 60 ml/min (Cockcroft & Gault equation)

Key exclusion criteria

1) Severe complication such as severe heart disease, high blood pressure, diabetes, intractable infections, acute peptic ulcer, severe psychiatric disease
2) Active double cancer including concurrent or metachronous tumor within five years, except for lesion equivalent to carcinoma in situ or intramucosal cancer which is completely treated by local therapeutic procedure
3) Patients with tumor directly infected rectum
4) Previous history of radiotherapy for targeted lesion
5) Conditions that attending physicians consider unsuitable for this clinical study due to medical or psychological issues

Target sample size

21

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Daisaku Yoshida

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Division name

Department of Radiation Oncology

Zip code

Address

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN

TEL

045-520-2222

Email

d.yoshida@kcch.jp

Name of contact person

1st name
Middle name
Last name	Dr. Daisaku Yoshida

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Division name

Ion-beam Radiation Oncology Center

Zip code

Address

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture, JAPAN

TEL

045-520-2222

Homepage URL

Email

d.yoshida@kcch.jp

Institute

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Institute

Department

Personal name

Organization

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

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

Date of disclosure of the study information

2018

Year

10

Month

29

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

2018

Year

10

Month

19

Day

Date of IRB

Anticipated trial start date

2018

Year

10

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

10

Month

29

Day

Last modified on

2018

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039435