Status:
UNKNOWN
Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Gastrointestinal Stromal Tumors
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study evaluates the efficacy and safety of surgical intervention in patients with focally progressive GISTs after imatinib treatment. The enrolled patients will be randomized to receive surgery f...
Detailed Description
Imatinib is the first-line treatment for advanced GIST with a satisfactory response rate, but complete remission rarely happens. Besides, drug resistance can occur during the treatment and the median ...
Eligibility Criteria
Inclusion
- Patients whose pathology is clearly diagnosed as recurrent/metastatic GIST, have undergone standardized imatinib treatment, and the disease progresses during the treatment;
- The lesions with progress are confined to one organ, and the number is ≤3; after evaluation by relevant professional surgeons or multidisciplinary team discussion, it is considered that the progressive lesions can be completely and safely removed without affecting the organ function;
- Age: 18 years old ≤ age ≤ 75 years old;
- No other malignant tumors occurred within five years;
- Eastern Cooperative Oncology Group (ECOG) physical status score \<2 points;
- American Society of Anesthesiologists (ASA) score \<3 points;
- There are no restrictions on gender and race;
- Patients with informed consent.
Exclusion
- The patient has other serious comorbidities and cannot tolerate surgery: such as severe cardiopulmonary disease, cardiac function in grade 2 or lower, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), etc., combined with severe diabetes and/or kidney Insufficient function, combined with severe hepatitis and/or functional Child-pugh grade C or a grade B that is clearly difficult to correct, combined with severe malnutrition;
- Patients with extensive disease progress;
- Imatinib primary resistant patients;
- Patients with other diseases requiring simultaneous surgical intervention, such as gallstones; inguinal hernia;
- Disease-related complications such as bleeding, perforation, and obstruction;
- Pregnant or lactating women;
- The patient has a serious mental illness;
- Patients with other malignant tumors within five years;
- The patient has participated in or is participating in other clinical studies or is using other tyrosinekinase inhibitors.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03862768
Start Date
July 1 2019
End Date
December 1 2021
Last Update
March 5 2019
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