UMIN-CTR Clinical Trial

Public title

Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma.

Acronym

Phase II study of VAC2.2/VI therapy for patients with newly diagnosed intermediate rhabdomyosarcoma.

Scientific Title

Phase II study of vincristine, actinomycin-D, cyclophosphamide and irinotecan for patients with newly diagnosed intermediate rhabdomyosarcoma.

Scientific Title:Acronym

Phase II study of VAC2.2/VI therapy for patients with newly diagnosed intermediate rhabdomyosarcoma.

Region

Japan

Condition

rhabdomyosarcoma

Classification by specialty

Hematology and clinical oncology	Obstetrics and Gynecology	Pediatrics
Oto-rhino-laryngology	Orthopedics	Urology
Neurosurgery	Plastic surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Determine the safety and efficacy of VAC 2.2 (vincristine, actinomycin-D, cyclophosphamide) therapy and VI (vincristine and irinotecan) therapy for patients with intermediate rhabdomyosarcoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Event free survival

Key secondary outcomes

overall survival
time to treatment failure
overall response rate
frequency and grade of adverse event
frequency and grade of irinotecan-related adverse event in relation with UGT1A1 gene polymorphism
diagnostic and prognostic significance of serum miR-206 value
quality control of radiation therapy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

chemotherapy 43 weeks
VAC1.2 therapy 1 cycles
vincristine 1.5mg/m2 day 1
dactinomycin 0.045mg/kg day 1
cyclophosphamide 1.2g/m2 day1
VAC2.2 therapy 8 cycles
vincristine 1.5mg/m2 day 1
dactinomycin 0.045mg/kg day 1
cyclophosphamide 2.2g/m2 day1
VI therapy 5 cycles
vincristine 1.5mg/m2 day 1
irinotecan 50mg/m2 day 1-5
surgery
radiotherapy

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

Not applicable

Age-upper limit

30

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed newly diagnosed rhabdomyosarcoma (RMS), meeting criteria for intermediate.
2) Age younger than 30 years old.
3) Initiation of chemotherapy within 42 days after first surgery.
4) No prior history of malignancy.
5) ECOG 0-2 (>=16 years old) or Lansky 50-100% (< 16 years old)
6) Patients must have sufficient organ function.
7) All patients and/or their parents or legal guardians must sign a written informed consent.

Key exclusion criteria

1) patients with synchronous or metachronous concomitant malignancies
2) patients with Charcot-Marie-Tooth disease or varicella
3) patients with uncontrollable complications
Interstitial pneumonia, pulmonary fibrosis, severe emphysema
Uncontrollable diabetes mellitus
Uncontrollable hypertension
Severe electrocardiogram abnormality or clinically significant heart disease(heart failure, myocardial infarction, angina pectoris)
Liver failure, cirrhosis
Renal failure
4) patients with contraindication of drugs used in this study
5) Female patients who are pregnant or breastfeeding mother or patients considering pregnancy
6) Patients with any other inappropriate condition judged by physician

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Ako Hosono

Organization

National Cancer Center Hospital East

Division name

Division of Pediatric Oncology

Zip code

Address

6-5-1 Kashiwanoha Kashiwa-shi Chiba

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

Division of Pediatric Oncology

Zip code

Address

6-5-1 Kashiwanoha Kashiwa-shi Chiba

TEL

04-7133-1111

Homepage URL

Email

ahosono@east.ncc.go.jp

Institute

Japan Rhabdomyosarcoma Study Group

Institute

Department

Personal name

Organization

Grant for innovative clinical cancer research from the Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

Date of disclosure of the study information

2016

Year

10

Month

01

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

2016

Year

05

Month

20

Day

Date of IRB

2019

Year

02

Month

14

Day

Anticipated trial start date

2017

Year

04

Month

01

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

06

Day

Last modified on

2020

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027581