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

Primary Purpose

Gastrointestinal Stromal Tumors, Surgery

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

surgery

Imatinib 400 MG

Imatinib escalation

Sunitinib

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal Stromal Tumors, imatinib-resistant, focal progression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgery following imatinib

Imatinib escalation or sunitinib

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Overall survival will be defined as time from the start of treatment until death from any cause

Full Information

NCT ID

NCT03862768

First Posted

February 27, 2019

Last Updated

March 1, 2019

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03862768

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 2019 (Anticipated)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Stromal Tumors, Surgery

Keywords

Gastrointestinal Stromal Tumors, imatinib-resistant, focal progression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery following imatinib

Arm Type

Experimental

Arm Description

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

Arm Title

Imatinib escalation or sunitinib

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

surgery

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Imatinib 400 MG

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Imatinib escalation

Intervention Description

Imatinib 600 MG/d

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Intervention Description

Sunitinib 37.5 MG/d

Primary Outcome Measure Information:

Title

Progression-free Survival

Description

Time Frame

one year

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival will be defined as time from the start of treatment until death from any cause

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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