AzTrials
AzTrials

SarcomaPhase 2NCT00278876

Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation

A Phase 2 study testing Imatinib mesylate (Glivec) in people with Sarcoma and Gastrointestinal Stromal Tumors, run by Asan Medical Center at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The presence of c-kit mutation is an independent poor prognostic factor for relapse in addition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) in localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Gastrointestinal Stromal Tumors
What is being tested?
Imatinib mesylate (Glivec)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
4 sitesSouth Korea
Study dates
Apr 2005to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117)
  • Tumor size > 5 cm and mitotic rate > 5/50HPF(High Power Field), or tumor size > 10 cm irrespective of mitotic rate, or mitotic rate > 10/50 HPF irrespective of tumor size.
  • Presence of mutation in exon 11 of c-kit gene.
  • Surgery performed from 3 weeks to 8 weeks before administration of Imatinib mesylate.
  • No evidence of residual macroscopic and microscopic disease after surgery.
  • Absence of distant metastases
Show all 18Show fewer
  • No prior radiation therapy, no prior chemotherapy, no prior therapy with Imatinib mesylate, or any other molecular targeted or biological therapy.
  • Age 18 yrs or older
  • ECOG(Eastern Cooperative Oncology Group electrocorticogram) performance status = 0-2
  • No New York Heart Association (NYHA) Class 3~4 cardiac problems
  • Absence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as human immunodeficiency virus (HIV) infection, etc.).
  • No ongoing pregnancy or nursing..
  • No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease-free for 5 years.
  • No use of coumarin derivatives at the time of treatment start.
  • Adequate liver function, as defined by a serum bilirubin < 1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 IULN, obtained within 7 days prior to randomization.
  • Adequate renal function, as defined by a serum creatinine < 1.5 x IULN, obtained within 7 days prior to randomization.
  • Absolute neutrophil count (ANC) > 1.5 x 109/l and a platelet count > 100 x 109/l obtained within 7 days prior to randomization. Baseline hemoglobin > 9 g/dl (this may be achieved by transfusions if needed).
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • National Cancer Center

    Goyang

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Phase II Study of Imatinib Mesylate as Adjuvant Treatment in High-relapse Risk Localized Gastrointestinal Stromal Tumors With C-kit Mutation

The presence of c-kit mutation is an independent poor prognostic factor for relapse in addition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) in localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of high-risk for relapse according to National Institute of Health (NIH) consensus guideline (tumor size > 10 cm or mitotic count > 10/50 HPF) also have high-risk of relapse. Until recently, there has been no effective therapy for advanced, unresectable GISTs. However, a new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11 mutation is the strongest prognostic factor for better response and survival. It is reasonable to try imatinib in an earlier and minimal residual status especially for patients at higher risk of relapse and a higher probability of response to imatinib.

Being tested
Imatinib mesylate (Glivec)
Keywords
GIST, Imatinib, Adjuvant therapy, Kit mutation
Medical subject headings
Sarcoma, Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib mesylate (Glivec)Drug

    Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks

Study groups in NCT00278876
Study groupRoleWhat they receive
imatinib mesylateExperimentalpatients receiving adjuvant imatinib mesylate
Receives: Drug: Imatinib mesylate (Glivec)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year Relapse Free Survival Rate

    Measured: 2 years

Secondary outcomes (2)

  1. 2-year Overall Survival Rate

    Measured: 2 years

  2. Toxicity Profile

    Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib

    Measured: Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study startApr 2005
  3. Primary completionAug 2007
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00278876
Sponsor's protocol ID
AMC0501
Other IDs
CSTI571BKR08
Status last verified
Jan 2020
First submitted
17 Jan 2006
Last updated
7 Jan 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib mesylate (Glivec) in people with Sarcoma and Gastrointestinal Stromal Tumors, run by Asan Medical Center at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Relapse Free Survival Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00278876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in