UMIN-CTR Clinical Trial

Public title

A randomized phase II trial of postoperative adjuvant therapy with imanitib for 1 Year versus 6 months in patients with gastrointestinal stromal tumors

Acronym

Randomized trial of adjuvant therapy with imanitib for 1 year versus 6 months in GIST patients

Scientific Title

A randomized phase II trial of postoperative adjuvant therapy with imanitib for 1 Year versus 6 months in patients with gastrointestinal stromal tumors

Scientific Title:Acronym

Randomized trial of adjuvant therapy with imanitib for 1 year versus 6 months in GIST patients

Region

Japan

Condition

Gastrointestinal stromal tumor (GIST)

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Comparative efficacy and safety of 1-year versus 6-month adjuvant therapy with imanitib in GIST patients who underwent curative resection for new-onset disease and who were judged as being at intermediate or high risk (including clinical malignant) of recurrence according to risk stratification criteria

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Recurrence-free survival

Key secondary outcomes

Overall survival; treatment completion rate; the relationship of mutations of c-kit and PDGFRA as well as mRNA expression of their related factors to survival period (recurrence-free survival and overall survival); and adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Imanitib 400 mg/day for 1 year

Interventions/Control_2

Imanitib 400 mg/day for 6 months

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) A confirmed diagnosis of GIST by immunohistochemical test using resected sample or gene mutation test
2) Judgement as being at intermediate or high risk (including clinical malignant) according to risk stratification criteria
3) New-onset lesions (regardless of their primary sites)
4) Macroscopic curative resection (R0 or R1) has been carried out.
5) Judgement as being able to receive imanitib therapy within 12 weeks after surgery
6) Adequate organ function defined as indicated by the following blood test findings obtained within 4 weeks before enrollment
Neutrophils count: >=1,500/mm3
Platelet count: >=100,000/mm3
Total bilirubin: <=1.5 times the upper limit of normal (ULN)
AST(sGOT): <=2.5 times the ULN
ALT(sGPT): <=2.5 times the ULN
Creatinine: <=1.5 times the ULN
7) An ECOG performance status of 0 or 1
8) Age 20 to <80 years old
9) Written informed consent by the patient to participation in the study

Key exclusion criteria

1) Familial GIST or GIST complicated with von Recklinghausen disease (NF type 1)
2) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years). Carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) that are judged as having been cured by local treatment is not included in active double cancer.
3) Prior chemotherapy, radiotherapy, or immunotherapy after resection of lesions
4) Prior treatment with imanitib
5) Cardiac disease assigned to NYHA class III or IV
6) Women who are pregnant, breast-feeding, or planning to become pregnant
7) Active mycosis and other infections
8) Other conditions judged as inappropriate for the study by the investigator

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Toshimasa Tsujinaka

Organization

Osaka National Hospital

Division name

Department of Surgery

Zip code

Address

2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan

TEL

06-6942-1331

Email

tsujinaka@hosp.kaizuka.osaka.jp

Name of contact person

1st name
Middle name
Last name	Yukinori Kurokawa

Organization

Osaka University

Division name

Department of Gastroenterological Surgery

Zip code

Address

2-2-E2, Yamadaoka, Suita-shi, Osaka

TEL

06-6879-3251

Homepage URL

Email

ykurokawa@gesurg.med.osaka-u.ac.jp

Institute

Kinki GIST Study Group

Institute

Department

Personal name

Organization

Kinki GIST Study Group

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2007

Year

12

Month

17

Day

URL releasing protocol

Publication of results

Partially published

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

Completed

Date of protocol fixation

2007

Year

11

Month

07

Day

Date of IRB

Anticipated trial start date

2007

Year

12

Month

01

Day

Last follow-up date

2016

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

12

Month

15

Day

Last modified on

2018

Year

12

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001140