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Completed

NCT Number: NCT04343456

Salvage Surgery for Patients With Metastatic GIST With Rego

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.

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Gastrointestinal Diseases Gastrointestinal Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital Linkou Branch

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Systemic progression of disease
  • ASA classification > 3

Treatment and study plan

Salvage surgery with massive debulking

Procedure

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

Primary outcomes

  1. Overall survival

    Time frame: 01/2014~12/2019

    the time period from start regorafenib to death

  2. Disease free survival

    Time frame: 01/2014~12/2019

    the time period after salvage surgery to disease reprogression

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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