Salvage Surgery for Patients With Metastatic GIST With Rego

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04343456
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Actual Duration (Months): 73.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors; Metastasis; Disease Progression	Procedure: Salvage surgery with massive debulking

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Analysis of Benefit From Salvage Surgery for Highly Selected Patients With Metastatic Gastrointestinal Stromal Tumors Receiving Regorafenib Facing Local Progression
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Feb 28, 2020

Outcome Measures

Primary Outcome Measures

1. Overall survival [01/2014~12/2019]

   the time period from start regorafenib to death

2. Disease free survival [01/2014~12/2019]

   the time period after salvage surgery to disease reprogression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital Linkou Branch	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

• Study Director: Chun Nan Yeh, MD., Chang Gung Memorial Hospital, Linkuo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chun-Nan Yeh, Principal investigator, Head of General Surgery, and Professor of Surgery, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04343456
• Other Study ID Numbers: Rego_op
• First Posted: Apr 13, 2020
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Chun-Nan Yeh, Principal investigator, Head of General Surgery, and Professor of Surgery, Chang Gung Memorial Hospital: regorafenib; Gastrointestinal Stromal Tumors; Metastasis; local progression; surgery
• Additional relevant MeSH terms: Neoplasm Metastasis; Gastrointestinal Stromal Tumors; Disease Progression

Study Results

No Results Posted as of Apr 14, 2020