UMIN-CTR Clinical Trial

Public title

Chemotherapy consists of Adriamycin and Ifosfamide for the patients with high grade primary bone sarcoma except for Ewing sarcoma over 41, Phase II trial

Acronym

AI for bone sarcomas over 41-PII

Scientific Title

Chemotherapy consists of Adriamycin and Ifosfamide for the patients with high grade primary bone sarcoma except for Ewing sarcoma over 41, Phase II trial

Scientific Title:Acronym

AI for bone sarcomas over 41-PII

Region

Japan

Condition

patients with high grade primary bone sarcoma except for Ewing sarcoma over 41

Classification by specialty

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of Chemotherapy consists of Adriamycin and Ifosfamide for the patients with high grade primary bone sarcoma except for Ewing sarcoma over 41 years old.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

3-year progression- free survival

Key secondary outcomes

Proportion of completion of preoperative chemotherapy without progression disease, 5-year progression- free survival, progression- free survival, overall survival, disease progression rate, preoperative progression rate, adverse event, postoperative complication rate, the ratio of the patients who were performed limb sparing surgery, function of postoperative limb

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Three courses of preoperative chemotherapy with adriamycin (30mg/m2/day, day 1-2) and ifosphamide (2g/m2/day, day 1-5) every three weeks followed by surgical resection and three courses of postperative chemotherapy same as preoperatively

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

Age-lower limit

41

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Untreated case with a histological diagnosis of grade 2 or 3 (FNCLCC histological grading system) primary bone sarcoma except for Ewing sarcoma aged over 41 using open biopsy specimen.
2. 10 or more unstained tumor tissue slides are available
3. Resectable tumor
4. Measurable lesion on MRI axial section
5. ECOG performance status 0 or 1
6. Age between 20 and 70 years
7. No metastasis
8. Sufficient organ function with following condition;
1)Neutrophil count>1500/mm3
2)Platelet count>10x104/mm3
3)Hemoglobin>8.0g/dl
4)Alanine aminotransferase, Asparate aminotransferase <2.5 ULN (upper limit of normal)
5)Blood Bilirubin<1.5mg/dl
6)Creatinine<1.5mg/dl
7)CCr>60ml/min
8)No abnormal ECG findings
9)Written informed consent

Key exclusion criteria

1) Severe comorbid illness
2) Active infection
3) Synchronous or metachronous (within 5 years) malignancies
4) History of chemotherapy using ADR and/or IFO
5) Poorly renal or bladder function
6) Severe myelosuppression
7) Abnormal heart function
8) Patients having a pacemaker
9) Patients requiring pentostatin
10) Women in pregnant, possibly pregnant or breast feeding
11) Patients requiring systemic steroid medication
12) Psychiatric disease
13) Positive HBs antigen, HBs antibody, or HBc antibody

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Akira Kawai

Organization

National Cancer Center Hospital

Division name

Dept. of Musculoskeletal Oncology and Rehabilitation

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Email

akawai@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Akihito Nagano

Organization

Gifu University school of medicine

Division name

The department of Orthopaedic surgery

Zip code

Address

1-1 Yanagido, Gifu

TEL

058-230-6333

Homepage URL

Email

a-nagano@lucky.odn.ne.jp

Institute

Japanese Musculoskeletal Oncology Group; JMOG

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

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

国立病院機構北海道がんセンター（北海道）
札幌医科大学（北海道）
新潟大学（新潟県）
岩手医科大学（岩手県）
東北大学病院（宮城県）
福島県立医科大学医学部（福島県）
千葉県がんセンター（千葉県）
慶應義塾大学（東京都）
国立がん研究センター中央病院（東京都）
日本大学医学部（東京都）
がん研有明病院（東京都）
帝京大学医学部（東京都）
東京大学（東京都）
がん・感染症センター都立駒込病院（東京都）　
順天堂大学（千葉県）
東京歯科大学市川総合病院（千葉県）
日本医科大学付属病院（東京都）
日本医科大学付属多摩永山病院（東京都）
山梨大学医学部（山梨県）
栃木県立がんセンター（栃木県）
埼玉県立がんセンター（埼玉県）
自治医科大学付属さいたま医療センター（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
静岡県立静岡がんセンター（静岡県）　
愛知県がんセンター中央病院（愛知県）
名古屋大学医学部（愛知県）
岐阜大学医学部（岐阜県）
三重大学医学部（三重県）
富山大学医学部（富山県）
京都大学医学部付属病院（京都府）
大阪大学医学部（大阪府）
大阪府立成人病センター（大阪府）
国立病院機構大阪医療センター（大阪府）
大阪市立大学医学部（大阪府）
松下記念病院（大阪府）
奈良県立医科大学（奈良県）
神戸大学（兵庫県）
近畿大学（大阪府）
兵庫医科大学（兵庫県）
岡山大学病院（岡山県）
米子医療センター（鳥取県）
香川大学医学部（香川県）
高知大学（高知県）
徳島大学（徳島県）

Date of disclosure of the study information

2015

Year

01

Month

10

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

Terminated

Date of protocol fixation

2014

Year

11

Month

16

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

17

Day

Last modified on

2015

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018590