UMIN-CTR Clinical Trial

Public title

Randomized phase II study of two cross-over sequences, Gemcitabine/ docetaxel (A) and temozolomide/etoposide (B), for relapsed or refractory Osteosarcoma

Acronym

Cross-over rPII study for refractory osteosarcoma

Scientific Title

Randomized phase II study of two cross-over sequences, Gemcitabine/ docetaxel (A) and temozolomide/etoposide (B), for relapsed or refractory Osteosarcoma

Scientific Title:Acronym

Cross-over rPII study for refractory osteosarcoma

Region

Japan

Condition

Relapse or refractory osteosarcoma

Classification by specialty

Pediatrics	Orthopedics	Adult
Child

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the safety and efficacy of temozolomide (TMZ) and etoposide (VP) ,Gemcitabine(GEM) and docetaxel(DOC)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression-Free Survival

Key secondary outcomes

response rate
Overall Survival
Adverse events profile

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TMZ+VP: 5 day schedule oral TMZ and 12 day schedule oral VP, to be repeated every 4 weeks

Interventions/Control_2

GEM+DOC:intravenous GEM day1,8 and DOC day8, to be repeated every 3 weeks

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

1

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1.relapsee osteosarcoma
2.relapse or progression following disease-specific standard chemotherapies
3. evidence of progression or stable disease on imaging studies
4.aged 60 or less
5. no prior chemotherapy containing either Gemcitabine, Docetaxel or temozolomide
6.ECOG Performance Status of 0-2
7.confirming the following laboratory results within 14 days
(1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 5,000/mm~3 (at least 3days since prior concentrated platelet transfusion)
(3) serum total Bilirubin <= 1.2mg/dl
(4) Creatinine adjusted according to age as follows:
<= 0.6 mg/dl (1 year-23 months)
<= 0.8 mg/dl (2 years-5 years)
<= 0.9 mg/dl (6 years-9 years)
<= 1.1 mg/dl (10 years-12 years [male])
<= 1.0 mg/dl (10 years-12 years [female])
<= 1.5 mg/dl (13 years-15 years [male])
<= 1.2 mg/dl (13 years and over [female])
<= 1.7 mg/dl (16 years and over [male])
8. > 14 days since prior other antitumor cytotoxic agents
9.> 21 days since prior non-palliative chest irradiation or 14 days since prior not palliative radiation therapy
10.Not diagnosed as interstitial pneumonia, pulmonary emphysema nor pulmonary fibrosis with chest CT finding
11. > 7 days since prior surgery (including open biopsy)
12. Written informed consent

Key exclusion criteria

1.Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment
2. Active infection requiring systemic medication
3.abnormality in electrocardiogram tested within 28 days, requiring intervention
4.respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion
5.Women in pregnant, possibly pregnant or breast feeding
6.Psychiatric disease
7.Inadequate physical condition judged by investigator.

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Ako Hosono

Organization

National Cancer Center Hospital East

Division name

Pediatric Oncology Division

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Email

ahosono@east.ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Ako Hosono

Organization

National Cancer Center Hospital East

Division name

Pediatric Oncology Division

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Homepage URL

Email

ahosono@east.ncc.go.jp

Institute

Group for "combination chemotherapies for refractory Adolescent and Young Adult solid tumors "

Institute

Department

Personal name

Organization

Health and Labor Sciences Research Grant

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

609

Org. issuing International ID_1

Niigata Cancer Center Hospital pediatric division

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

07

Month

15

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

2015

Year

06

Month

30

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

14

Day

Last modified on

2019

Year

01

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021189