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

NCT ID: NCT03862768

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-12-31

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

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 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.

Conditions

Gastrointestinal Stromal Tumors; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery following imatinib

Surgery requires at least removal of all drug-resistant lesions. Imatinib 400 MG/d should be taken once the patients resume oral diet.

Group Type: EXPERIMENTAL

surgery

Intervention Type: PROCEDURE

Surgery requires at least removal of all drug-resistant lesions.

Imatinib 400 MG

Intervention Type: DRUG

Imatinib 400 MG/d should be taken once the patients resume oral diet

Imatinib escalation or sunitinib

Escalation of imatinib or replacement of sunitinib are both conventional salvage treatments for imatinib-resistant GISTs. There is no high-level evidence to suggest which method is better. So patients are free to choose imatinib 600 MG/d or sunitinib 37.5 MG/d

Group Type: ACTIVE_COMPARATOR

Imatinib escalation

Intervention Type: DRUG

Imatinib 600 MG/d

Sunitinib

Intervention Type: DRUG

Sunitinib 37.5 MG/d

Interventions

surgery

Surgery requires at least removal of all drug-resistant lesions.

Intervention Type: PROCEDURE

Imatinib 400 MG

Imatinib 400 MG/d should be taken once the patients resume oral diet

Intervention Type: DRUG

Imatinib escalation

Imatinib 600 MG/d

Intervention Type: DRUG

Sunitinib

Sunitinib 37.5 MG/d

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

B2018-297

Identifier Type: -

Identifier Source: org_study_id