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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2020
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Between 2014 and 2019, 41 metastatic GIST patients received regorafenib therapy. 35 out of 41 metastatic GIST patients who were on regorafenib therapy facing progression and 15 experienced local progression underwent salvage surgery. Thirty-five of 41 (85.4 %) pre-treated GIST patients receiving regorafenib who experienced disease progression after a median follow-up of 12.4 months of regorafenib use. 15 out of 35 (42.9%) metastatic GIST patients receiving regorafenib facing progression underwent salvage surgery.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Salvage surgery with massive debulking
For patients with regorafenib treatment and facing local progression, we remove the tumor with progression and achieve cytoreduction.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Linkou Branch Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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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