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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034677
Receipt No. R000039435
Scientific Title A phase II clinical trial of Carbon-ion radiotherapy for patients with locally advanced adenocarcinoma of the uterine cervix
Date of disclosure of the study information 2018/10/29
Last modified on 2018/10/29

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Basic information
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
Condition Locally advanced adenocarcinoma of the uterine
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department

Funding Source
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 29 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
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

Progress
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
Other related information

Management information
Registered date
2018 Year 10 Month 29 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039435

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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