Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of Gastrointestinal Stromal Tumor (GIST)
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| ClinicalTrials.gov Identifier: NCT00116935 |
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Recruitment Status :
Completed
First Posted : July 1, 2005
Last Update Posted : December 30, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcoma | Drug: imatinib mesylate Drug: imatinib | Phase 3 |
This is an open-label, randomized, prospective, phase III, multicenter study carried out in the Nordic countries and in Germany. Following macroscopically complete surgery, the study participants will be allocated to receive imatinib either for 12 or for 36 months. At randomization, the patients are stratified into 2 strata: 1) local disease (1 GIST tumor); 2) intra-abdominal implants or resectable intra-abdominal/hepatic metastases, or intra-abdominal spillage is present, or R1 surgery has been carried out (microscopic disease has been left behind). The imatinib dose is 400 mg/day administered with food. Imatinib dose adjustments are made as per protocol.
Medical history, current medication, weight, height, and ECOG performance status are recorded prior to study entry. Physical examination, blood cell counts, blood biochemistry, pregnancy test, chest X-ray or CT, and CT or MRI of the abdomen and pelvis are carried out/measured prior to study entry. FDG-PET is an optional staging examination. Research serum samples are collected for banking prior to initiating imatinib and at 6-month intervals during the study. Tumor tissue is reviewed centrally to confirm the histological diagnosis of GIST, and KIT and PDGFRA gene mutation analyses will be performed from stored GIST tissue.
The study participants are monitored during adjuvant treatment and following adjuvant treatment. Physical examination, weight and ECOG performance status are assessed at 4- to 26-week intervals. Adverse events are collected using structured forms at the times of the evaluation visits. Blood cell counts and blood biochemistry are measured at 2- to 6-week intervals during imatinib therapy, and at 6-month intervals following completion of adjuvant therapy. CT or MRI examinations of the abdomen and pelvis are performed at 6-month intervals during the study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Short (12 Months) Versus Long (36 Months) Duration of Adjuvant Treatment With the Tyrosine Kinase Inhibitor Imatinib Mesylate of Operable GIST With a High Risk of Recurrence |
| Study Start Date : | February 2004 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
1 year of adjuvant imatinib mesylate 400 mg/day orally
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Drug: imatinib mesylate
imatinib 400 mg/day orally qd for 12 months
Other Name: Gleevec Drug: imatinib imatinib 400 mg/d orally qd for 36 months
Other Name: Gleevec |
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Experimental: 2
3 years of adjuvant imatinib mesylate 400 mg/day orally
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Drug: imatinib
imatinib 400 mg/d orally qd for 36 months
Other Name: Gleevec |
- Recurrence-free survival [ Time Frame: 5 years ]
- Adverse effects [ Time Frame: 5 years ]
- Survival [ Time Frame: 5 years ]
- GIST-specific survival [ Time Frame: 5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 or older
- Histologically documented diagnosis of GIST
- Resectable GIST
- GIST removed at open surgery
- Immunohistochemical documentation of GIST (immunostaining for KIT/CD117)
- High risk of tumor recurrence as defined as one of the following: 1) the largest tumor diameter greater than 10.0 cm (measured by a pathologist, with any mitotic count); 2) mitotic count over 10 mitoses per 50 high power fields (HPFs) (with any tumor size); the largest tumor diameter larger than 5.0 cm and the mitotic count is over 5/50 HPFs; 4) tumor spillage into the abdominal cavity at surgery (or tumor rupture). No residual tumors must be present at laparotomy, or in postoperative CT or MRI examinations. Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are also allowed to enter study.
- Performance status 0, 1, or 2 (ECOG)
- Adequate organ function, defined as follows: total bilirubin <1.5 x ULN (upper limit of normal), serum AST (SGOT) and ALT (SGPT) <2.5 x ULN, creatinine <1.5 x ULN, ANC (neutrophil count) >1.5 x 10^9/L, platelets >100 x 10^9/L.
- Negative pregnancy test (females with childbearing potential)
- Written, voluntary informed consent
Exclusion Criteria:
- Inoperable or metastatic GIST
- Less than 1 week or more than 12 weeks has elapsed from surgery
- Recurrent GIST
- Patient has received any investigational agents within 28 days as calculated from the first day of the study drug dosing
- Patient is less than 5 years free from another primary malignancy
- Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- Female patients who are pregnant or breast-feeding
- Patient has severe or uncontrolled medical disease (i.e. uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection). Concurrent use of warfarin or acetaminophen are not allowed with imatinib.
- Chronic liver disease
- Known diagnosis of human immunodeficiency virus (HIV) infection
- Patient has received chemotherapy for GIST
- Patient has received neoadjuvant imatinib therapy prior to randomization
- Radiotherapy to 25% or more of the bone marrow
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116935
| Sweden | |
| Scandinavian Sarcoma Group, Southern Swedish Regional Tumour Registry, Lund University Hospital | |
| Lund, Sweden, SE-221 85 | |
| Principal Investigator: | Heikki Joensuu, M.D. | Department of Oncology, Helsinki University Central Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Scandinavian Sarcoma Group |
| ClinicalTrials.gov Identifier: | NCT00116935 |
| Other Study ID Numbers: |
SSGXVIII/AIO |
| First Posted: | July 1, 2005 Key Record Dates |
| Last Update Posted: | December 30, 2011 |
| Last Verified: | December 2011 |
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Gastrointestinal stromal tumor GIST Sarcoma Imatinib Adjuvant therapy |
KIT PDGFRA Receptor tyrosine kinase Tyrosine kinase inhibitor |
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Sarcoma Gastrointestinal Stromal Tumors Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |