Salvage Surgery for Patients With Metastatic GIST With Rego

NCT04343456 | Completed

• 1 other identifier: Rego_op
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors; Metastasis; Disease Progression

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Overall survival

  the time period from start regorafenib to death

  01/2014~12/2019

• Disease free survival

  the time period after salvage surgery to disease reprogression

  01/2014~12/2019

Interventions

Salvage surgery with massive debulking PROCEDURE

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between 2014 and 2019, 41 metastatic GIST patients receiving regorafenib therap at Chang Gung Memorial Hospital, Linkou, Taiwan were enrolled. All the patients were managed by a multidisciplinary GIST team composed of medical oncologists and surgical oncologists.

You may qualify if:

• Patients who is taking regorafenib after treatment failure by 1st line and 2nd line tyrosine kinase, namely Imatinib and Sunitinib.
• Patients with aforementioned condition and is facing local progression of disease or stationary disease.

You may not qualify if:

• Systemic progression of disease
• ASA classification \> 3

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasm Metastasis; Disease Progression

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Chun Nan Yeh, MD.

  Chang Gung Memorial Hospital, Linkuo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Head of General Surgery, and Professor of Surgery

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)