Metastasis Clinical Trial
Official title:
Analysis of Benefit From Salvage Surgery for Highly Selected Patients With Metastatic Gastrointestinal Stromal Tumors Receiving Regorafenib Facing Local Progression
NCT number | NCT04343456 |
Other study ID # | Rego_op |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2014 |
Est. completion date | February 28, 2020 |
Verified date | April 2020 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Some researches have shown surgery may acquire progression-free (PFS) benefit for selected patients with metastatic gastrointestinal stromal tumor (GIST) who received first-line imatinib and second-line sunitinib. However, impact of salvage surgery on pre-treated GIST patients receiving third-line regorafenib facing progression is not yet reported. Investigators retrospectively reviewed patients with regorafenib treatment with salvage surgery.
Status | Completed |
Enrollment | 41 |
Est. completion date | February 28, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion criteria: 1. Patients who is taking regorafenib after treatment failure by 1st line and 2nd line tyrosine kinase, namely Imatinib and Sunitinib. 2. Patients with aforementioned condition and is facing local progression of disease or stationary disease. Exclusion criteria 1. Systemic progression of disease 2. ASA classification > 3 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital Linkou Branch | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | the time period from start regorafenib to death | 01/2014~12/2019 | |
Primary | Disease free survival | the time period after salvage surgery to disease reprogression | 01/2014~12/2019 |
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