UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034677 |
|---|---|
| Receipt number | 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 10:45:31 |
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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
| Obstetrics 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
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
d.yoshida@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039435
