Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment

Surgery Clinical Trial

Official title:

Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment: A Prospective, Multicenter, Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03862768
• Other study ID #: B2018-297
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: December 2021

Study information

• Verified date: February 2019
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 following imatinib 400 milligram per day (MG/d) or only tyrosine kinase inhibitor (Imatinib 600 MG/d or Sunitinib 37.5 MG/d).

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 time of drug resistance is about 20-24 months. Once drug resistance occurs, the patient's condition will progress rapidly. As a salvage treatment, the effect of increasing the dose of imatinib or switching to sunitinib is very limited. Progress after imatinib treatment usually involves two conditions, focal progression and extensive progression. For local progression, all resistant lesions can be completely resected; extensive progression refers to resistance progression in multiple sites, and progressive lesions cannot be completely removed. The present study is aimed to assess the benefits of surgical resection of imatinib-resistant lesions in patients with localized disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients whose pathology is clearly diagnosed as recurrent/metastatic GIST, have undergone standardized imatinib treatment, and the disease progresses during the treatment;

2. 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;

3. Age: 18 years old = age = 75 years old;

4. No other malignant tumors occurred within five years;

5. Eastern Cooperative Oncology Group (ECOG) physical status score <2 points;

6. American Society of Anesthesiologists (ASA) score <3 points;

7. There are no restrictions on gender and race;

8. Patients with informed consent.

Exclusion Criteria:

1. 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;

2. Patients with extensive disease progress;

3. Imatinib primary resistant patients;

4. Patients with other diseases requiring simultaneous surgical intervention, such as gallstones; inguinal hernia;

5. Disease-related complications such as bleeding, perforation, and obstruction;

6. Pregnant or lactating women;

7. The patient has a serious mental illness;

8. Patients with other malignant tumors within five years;

9. The patient has participated in or is participating in other clinical studies or is using other tyrosinekinase inhibitors.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• Surgery

Intervention

Procedure:
• surgery
Surgery requires at least removal of all drug-resistant lesions.

Drug:
• Imatinib 400 MG
Imatinib 400 MG/d should be taken once the patients resume oral diet
• Imatinib escalation
Imatinib 600 MG/d
• Sunitinib
Sunitinib 37.5 MG/d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first.	one year
Secondary	Overall Survival	Overall survival will be defined as time from the start of treatment until death from any cause	one year