Salvage Surgery for Patients With Metastatic GIST With Rego

NCT ID: NCT04343456

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Stromal Tumors Metastasis Disease Progression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Salvage surgery with massive debulking

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chun-Nan Yeh

Principal investigator, Head of General Surgery, and Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Nan Yeh, MD.

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital, Linkuo

Locations

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Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Rego_op

Identifier Type: -

Identifier Source: org_study_id

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