- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413736
Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST
November 8, 2023 updated by: Heikki Joensuu
Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST With a High Risk for Recurrence: A Randomised Phase III Study
In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST) and have been treated with adjuvant imatinib for 3 years after surgery will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop imatinib (Arm B).
The study participants are required to have histologically verified GIST with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at surgery and 3 years of adjuvant imatinib.
The high risk of GIST recurrence is defined as one of the following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the microscope, non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture.
Study participants allocated to Arm A will receive imatinib 400 mg/day for 24 months after the date of randomization.
All study participants will be followed up using blood tests and computerized tomography (or MRI) of the abdomen.
The computerized tomography examinations will be performed at 6 month intervals.
A total of 300 patients will be entered to the study.
The study hypothesis is that adjuvant imatinib given for a total of 5 years may prevent some of the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years, and there may be a difference in the rate of GIST recurrence between the two groups.
Study Overview
Detailed Description
The study will accrue patients in several countries in the Europe.
Study Type
Interventional
Enrollment (Actual)
255
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heikki Joensuu, MD
- Phone Number: 358 094711
Study Contact Backup
- Name: Raija Husa
- Phone Number: 358 094711
Study Locations
-
-
-
Helsinki, Finland, 00029
- Helsinki University Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Morphological and immunohistological documentation of GIST (immunostaining for KIT and/or DOG-1 positive, or mutation of KIT or PDGFRA present in tumor tissue).
- Macroscopically complete surgical resection of GIST (either R0 or R1 resection).
- Mutation analysis of KIT and PDGFR genes has been carried out.
- A high risk of GIST recurrence; either gastric GIST with mitotic count >10/50 HPFs, or non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Adequate organ function.
- Female patients of childbearing potential must have a negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must have amenorrhea for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Patient willing to be followed up at the study site regardless of the result of randomization.
- Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.
Exclusion Criteria:
- Presence of distant metastases or local recurrence of GIST.
- Not willing to donate tumor tissue and/or blood samples for the study molecular studies.
- Presence of a substitution mutation at PDGFRA codon D842 (usually D842V).
- Administration of adjuvant imatinib longer than for 3 years is planned regardless of the result of randomization, or "life long" imatinib administration is planned.
- Prior adjuvant (+ neoadjuvant) therapy with imatinib mesylate for at least 35 months has not been completed, or the total duration of prior adjuvant (+ neoadjuvant) imatinib administration exceeds the total duration of 37 months.
- Neoadjuvant imatinib for a duration that exceeds 9 months.
- Longer than 4-week break during adjuvant imatinib administration.
- The dose of imatinib at completion of 3 years of adjuvant imatinib was 200 mg per day or less or greater than 800 mg per day.
- Patient has received any investigational anti-cancer agents during adjuvant imatinib or between completion of adjuvant imatinib and the date of randomization.
- Patient has been free of another malignancy for less than 5 years except if the other malignancy is not currently clinically significant nor requiring active intervention, or if the other malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Recent existence of any other malignant disease is not allowed.
- Patient with Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study entry).
- Female patients who are pregnant or breast-feeding.
- Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection).
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Patient with a significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imatinib
Imatinib 400 mg/day for 24 months.
|
Imatinib 400 mg/day
Other Names:
|
No Intervention: No imatinib
No further imatinib.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence-free survival
Time Frame: 5 years
|
Time from the date of randomization to GIST recurrence or death.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5 years
|
Time from the date of randomization to death.
|
5 years
|
GIST-specific survival
Time Frame: 5 years
|
Time from the date of randomization to the date of death considered to be caused by GIST.
|
5 years
|
Adverse effects
Time Frame: 5 years
|
Adverse effects considered to be related to the treatment.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heikki Joensuu, Helsinki University Central Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2033
Study Registration Dates
First Submitted
April 7, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimated)
April 10, 2015
Study Record Updates
Last Update Posted (Actual)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSGXXII
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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