gastrointestinal stromal tumor(GIST)
Conditions
Interventions
Arm A:imatinib + surgery
Arm B:imatinib
Sponsors
Cancer hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; performance status 0 to 3 (WHO scale); 2. Histologically confirmed GIST expressing CD117+;3. Recurrent /metastatic GIST (liver and/or abdominal cavity); no extra-abdominal metastases; 4. Measurable disease (RECIST) before start of imatinib; 5. Treatment with imatinib administered for 0-4 months; 6. No prior adjuvant treatment with imatinib; 7. Adequate hematologic and organ function; 8. Give written informed consent prior to study-specific screening procedure, with the understanding that the patient has the right to withdraw from the study at any time without prejudice.
Exclusion criteria
Exclusion criteria: 1. distant metastasis except liver metastasis; 2. pregnant or lactating women; 3. history of other malignancy within the past 5 years, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix; 4. be sensitive to drug; 5. any medical condition that contraindicates potential surgery; 6. any serious uncontrolled concomitant disease; 7. attended other clinical trials in recent 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-years Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactYingqiang Shi
Outcome results
None listed