MedTrace Logo

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

NCT03862768 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-03-05

No results posted yet for this study

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

Interventions

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

DRUG

Imatinib escalation

Imatinib 600 MG/d

DRUG

Sunitinib

Sunitinib 37.5 MG/d

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-06-30
Completion
2021-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03862768 on ClinicalTrials.gov