UMIN-CTR Clinical Trial

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

WHO Grade II diffuse astrocytoma

Classification by specialty

Radiology

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival, Response rate, Complete response rate, Completion of therapy , Adverse events, Serious adverse events

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

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）

Date of disclosure of the study information

2014

Year

07

Month

17

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

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 related information

Registered date

2014

Year

07

Month

17

Day

Last modified on

2015

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016807