UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II clinical trial of Carbon-ion radiotherapy for patients with locally advanced adenocarcinoma of the uterine cervix
Title of the study (Brief title)	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	Dr. Daisaku Yoshida
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Radiation Oncology
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	Dr. Daisaku Yoshida
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Ion-beam Radiation Oncology Center
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

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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