UMIN-CTR Clinical Trial

Public title

Randomized phase III Study in patients with ANaplastic glioma of radiotherapy with Temozolomide versus nimustine hydrochloride(ACNU) followed by temozolomide (JCOG1016, SANTA study(P-III))

Acronym

(JCOG1016, SANTA study(Phase-III))

Scientific Title

Randomized phase III Study in patients with ANaplastic glioma of radiotherapy with Temozolomide versus nimustine hydrochloride(ACNU) followed by temozolomide (JCOG1016, SANTA study(P-III))

Scientific Title:Acronym

(JCOG1016, SANTA study(Phase-III))

Region

Japan

Condition

anaplastic glioma

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 ACNU with radiotherapy as first-line therapy and temozolomide as second-line therapy for newly diagnosed anaplastic glioma, comparing to temozolomide with radiotherapy as first-line therapy and best physician's choice as second-line therapy.

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, Complete response rate, Response rate, Adverse events, Serious adverse events, Completion of first-line therapy

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

A:
first-line therapy
concomitant phase, temozolomide(75mg/m2, everyday from first day to last day of radiation), radiation (60 Gy/30 fr, 5 days/week)
maintainance phase, temozolomide (150-200mg/m2, day1-5, every 4 weeks) 12 cycles
second-line therapy (after recurrence)
best physician's choice

Interventions/Control_2

B:
first-line therapy
concomitant phase, ACNU(80mg/m2, day1 and day36 of radiation), radiation (60 Gy/30 fr, 5 days/week)
maintainance phase, ACNU (80mg/m2, day1 every 8weeks) 6 cycles
second-line therapy (after recurrence)
temozolomide (150-200mg/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 anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma) or anaplastic ganglioglioma.
For those who had additional surgery, he/she must meet a) or b).
a) diagnosed with anaplastic glioma after both primary and addtional surgeries.
b) diagnosed with low grade glioma after primary surgery and diagnosed with anaplastic glioma 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 history of carmustine implant or photodynamic therapy during the surgery.
4) No clinically systemic metastasis (Imaging study except chest X-ray is not mandatory.
5) More than 50% of tumor existing cerebrum and diencephalon.
6) Preoperative MRI revealed no tumor recognized in the optic nerve, olfactory nerve and pituitary gland.
7) Preoperative MRI revealed no multiple legions or dissemination.
8) Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume under consultation with radiation oncologist.
9) Preoperative and postoperative MRI revealed measurable or non-measurable disease.
10) Three to 20 days after surgery.
11) Aged 20 to 69 years old at registration.
12) ECOG performance status (PS) of 0, 1, 2 or 3 due to neurological signs caused by the tumor.
13) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is accepted.
14) Adequate organ function.
15) Tests for mutation of R132H on IDH1 gene by immunohistochemistry or PCR method is performed either from resected or biopsy samples.
16) 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) Uncontrolled diabetes mellitus or routine administration of insulin
8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
9) Interstitial pneumonia, fibroid lung, or severe lung emphysema
10) Gadolinium allergy
11) Positive HIV antibody
12) Potitive HBs antigen

Target sample size

230

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihiro Muragaki

Organization

Tokyo Women's Medical University

Division name

Department of Neurosurgery

Zip code

Address

8-1 Kawada-cho Shinjuku-ku Tokyo 162-8666 Japan

TEL

03-3353-8111(28652)

Email

ymuragaki@twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Takashi Maruyama

Organization

JCOG1016 Coordinating Office

Division name

Department of Neurosurgery, Tokyou Women's Medical University

Zip code

Address

8-1 Kawada-cho Shinjuku-ku Tokyo 162-8666 Japan

TEL

03-3353-8111(28652)

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）
北里大学病院（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

05

Month

29

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

03

Month

18

Day

Date of IRB

Anticipated trial start date

2014

Year

05

Month

29

Day

Last follow-up date

2025

Year

05

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

05

Month

29

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=R000016142