Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy (NCT01865565) | Clinical Trial Compass
CompletedNot Applicable
Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy
Taiwan51 participantsStarted 2013-01-01
Plain-language summary
Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective, multicenter, open, observational study in evaluation of safety and efficacy of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. The study will include an up to 28-day screening period, followed by receiving imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Locally advanced unresectable GIST without metastasis at
* EC junction requiring total gastrectomy,
* Duodenum requiring Whipple operation;
* Large GIST requiring multiviceral resection;
* Rectum: requiring APR.
* Histologically documentation with positive immunostaining for KIT (CD117)
* Patient age ≥ 18 years old
* ECOG performance status 0 or 1
* Patient must have the following post-operative laboratory values confirmed within 14 days prior to registration:
* Creatinine ≤ 1.5 times the institution ULN (upper limit of normal)
* WBC ≥ 3,000/mm3
* Platelets ≥ 100,000/mm3
* Total Bilirubin ≤ 1.5 times the institution ULN. NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study.
* AST ≤ 2.5 times the institution ULN
* ALT ≤ 2.5 times the institution ULN
* Female of childbearing potential must have negative serum pregnancy test. -- -NOTE: Post-menopausal women must be amenorrheic for at least 12 months to be deemed not of reproductive potential.
* Patient is willing to sign informed consent.
Exclusion Criteria
* Patient has received post-operative chemotherapy.
* Patient has received post-operative radiation therapy.
* Patient has received post-operative investigational treatment.
* Patient has received prior therapy with imatinib, or any other molecular targeted or biological therapy.
* Patient has had an active infection requiring antibiotics within 14 days prior to registrat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.