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Salvage Surgery for Patients With Metastatic GIST With Rego

Analysis of Benefit From Salvage Surgery for Highly Selected Patients With Metastatic Gastrointestinal Stromal Tumors Receiving Regorafenib Facing Local Progression

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04343456
Enrollment
41
Registered
2020-04-13
Start date
2014-01-01
Completion date
2020-02-28
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease Progression, Gastrointestinal Stromal Tumors, Metastasis

Keywords

regorafenib, Gastrointestinal Stromal Tumors, Metastasis, local progression, surgery

Brief 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.

Detailed 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.

Interventions

PROCEDURESalvage surgery with massive debulking

For patients with regorafenib treatment and facing local progression, we remove the tumor with progression and achieve cytoreduction.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival01/2014~12/2019the time period from start regorafenib to death
Disease free survival01/2014~12/2019the time period after salvage surgery to disease reprogression

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026