Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341257
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-21
Brief Title:
Efficacy and Toxicity of SCART
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
Efficacy and Toxicity of Stereotactic CentralCore Ablative Radiation Therapy SCART - A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is expected to enroll patients for a period of five years with a total of 30 participants It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm Systemic drug therapy may be administered concurrently The following inclusion criteria must be met for participation in the study age greater than or equal to 18 years Eastern Cooperative Oncology Group ECOG score 2 pathological confirmation of cancer diagnosis tumor with a maximum diameter greater than or equal to 5 cm one or more lesions not suitable for surgery patient has provided informed consent patient receives SCART and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication The patient will receive a dose of 21 Gy in 3 fractions with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume GTV boundary For certain patients an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy SBRT resulting in a total dose of 5 Gy 5 for the GTV boundary
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None