Salvage Surgery for Patients With Metastatic GIST With Rego

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343456
• Other study ID #: Rego_op
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Disease Progression
• Gastrointestinal Stromal Tumors
• Metastasis
• Neoplasm Metastasis

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