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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014578
Receipt No. R000016807
Scientific Title Randomized phase III study for unresectable WHO Grade II diffuse astrocytoma with radiotherapy alone or chemoradiotherapy with temozolomide(JCOG1303, DARTS (Phase-III))
Date of disclosure of the study information 2014/07/17
Last modified on 2015/07/13

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Basic information
Public title Randomized phase III study for unresectable WHO Grade II diffuse astrocytoma with radiotherapy alone or chemoradiotherapy with temozolomide(JCOG1303, DARTS (Phase-III))
Acronym (JCOG1303, DARTS (Phase-III))
Scientific Title Randomized phase III study for unresectable WHO Grade II diffuse astrocytoma with radiotherapy alone or chemoradiotherapy with temozolomide(JCOG1303, DARTS (Phase-III))
Scientific Title:Acronym (JCOG1303, DARTS (Phase-III))
Region
Japan

Condition
Condition WHO Grade II diffuse astrocytoma
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this Phase III study is to evaluate the superiority of radiotherapy with concomitant and adjuvant therapy with temozolomide for newly diagnosed unresectable WHO Grade II diffuse astrocytoma, comparing to radiotherapy alone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, Response rate, Complete response rate, Completion of therapy , Adverse events, Serious adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm A: Radiotherapy alone (50.4 Gy/28 fr, 5 days/week)
Interventions/Control_2 Arm B: Concomitant phase, temozolomide (75 mg/m2, every day from first day to last day of radiation), radiation (50.4 Gy/28 fr, 5 days/week)
Maintenance phase, temozolomide (150-200 mg/m2, day1-5, every 4 weeks) 12 cycles
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
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven WHO Grade II astrocytoma (diffuse astrocytoma, fibrillary astrocytoma, protoplasmic astrocytoma, gemistocytic astrocytoma)
For those who had additional surgery, he/she must meet a) or b).
a) diagnosed with WHO Grade II astrocytoma after both primary and addtional surgeries.
b) undiagnosed after ptimary surgery and diagnosed with WHO Grade II astrocytoma after additional surgery.
2) No history of previous therapy for tumor except craniotomy or biopsy (newly diagnosed tumor). Those who underwent additional surgery within 84 days after primary surgery are eligible.
3) No clinically systemic metastasis (Imaging study except chest X-ray is not mandatory).
4) 50% or more of the tumor existing in the cerebrum and diencephalon.
5) Postoperative MRI within 42 days after surgery revealed residual tumor.
(A) Tumor resection < 90%
(B) Tumor resection >=90% and <100%, and classified as high risk by EORTC low grade glioma score
*EORTC LGG score high risk includes at least three of the following conditions.
(1) age >= 40 years
(2) largest diameter of the tumor >= 60 mm
(3) tumor crossing the midline
(4) astrocytoma histology subtype
(5) presence of neurologic deficit
6) Preoperative MRI revealed no multiple legions or dissemination.
7) Preoperative and postoperative MRI revealed measurable or non-measurable disease.
8) Three to 42 days after surgery.
9) Aged 20 to 69 years old at registration.
10) KPS(Karnofsky performance status)of 70-100.
11) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is acceptable.
12) Adequate organ function.
13) Written informed consent.
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Active infectious meningitis
4) Body temperature >= 38 degrees Celsius at registration
5) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
6) Psychosis or with psychotic symptom
7) Continuous systemic use of steroid or immunosuppressant for disease except for brain tumor
8) Uncontrolled diabetes mellitus or routine administration of insulin
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
10) Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema
11) Gadolinium allergy
12) Positive HIV antibody
13) Potitive HBs antigen
Target sample size 260

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Narita
Organization National Cancer Center Central Hospital
Division name Department of Neurosurgery and Neuro-Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL 03-3542-2511(7082)
Email yonarita@ncc.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuji Miyakita
Organization JCOG1303 Coordinating Office
Division name National Cancer Center Central Hospital, Department of Neurosurgery and Neuro-Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL 03-3542-2511(7304)
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 北海道大学病院(北海道)
中村記念病院(北海道)
弘前大学医学部附属病院(青森県)
岩手医科大学(岩手県)
東北大学病院(宮城県)
山形大学医学部(山形県)
筑波大学医学医療系(茨城県)
埼玉医科大学国際医療センター(埼玉県)
千葉大学医学部(千葉県)
国立がん研究センター中央病院(東京都)
日本大学医学部附属板橋病院(東京都)
杏林大学医学部(東京都)
東京女子医科大学(東京都)
慶應義塾大学病院(東京都)
東京大学医学部(東京都)
横浜市立大学附属病院(神奈川県)
北里大学医学部(神奈川県)
新潟大学医歯学総合病院(新潟県)
静岡県立静岡がんセンター(静岡県)
名古屋大学医学部(愛知県)
藤田保健衛生大学(愛知県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
関西医科大学附属枚方病院(大阪府)
神戸大学医学部(兵庫県)
広島大学病院(広島県)
愛媛大学医学部附属病院(愛媛県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
長崎大学病院(長崎県)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)
宮崎大学医学部附属病院(宮崎県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 17 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
2014 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 17 Day
Last follow-up date
2029 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 17 Day
Last modified on
2015 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016807

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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