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

NCT03862768 | Unknown

• 1 other identifier: B2018-297
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gastrointestinal Stromal Tumors; Surgery

Keywords

Gastrointestinal Stromal Tumors; imatinib-resistant; focal progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  one year

Study Arms (2)

Surgery following imatinib

EXPERIMENTAL

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

Procedure: surgery; Drug: Imatinib 400 MG

Imatinib escalation or sunitinib

ACTIVE COMPARATOR

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

Drug: Imatinib escalation; Drug: Sunitinib

Interventions

surgery PROCEDURE

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

Surgery following imatinib

Imatinib 400 MG DRUG

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

Surgery following imatinib

Imatinib escalation DRUG

Imatinib 600 MG/d

Imatinib escalation or sunitinib

Sunitinib DRUG

Sunitinib 37.5 MG/d

Imatinib escalation or sunitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Surgical Procedures, Operative; Imatinib Mesylate; Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: July 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 5, 2019

Record last verified: 2019-02