Efficacy and Toxicity of SCART

Not Applicable

Withdrawn

• Conditions: Tumor Size Greater Than or Equal to 5 cm
• Interventions: Radiation: Stereotactic Central/Core Ablative Radiation Therapy (SCART)

• Registration Number: NCT06341257
• Lead Sponsor: Taichung Veterans General Hospital

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

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-31
• Study First Posted: 2024-04-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Primary Completion: 2025-04-08
• Study Completion: 2025-04-08
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age greater than or equal to 18 years
• ECOG score ≤ 2, pathological confirmation of cancer diagnosis
• Pathologically proved malignant 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

Exclusion Criteria

• Pregnant
• Life expectancy less than six months
• Uncontrolled angina, arrythmia, and congestive heart failure
• History of malignant pleural effusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCART	Stereotactic Central/Core Ablative Radiation Therapy (SCART)	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 GTV boundary.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	From date of radiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	the time from inclusion to disease progression or death from any cause.
Local Control (LC)	From date of radiotherapy until the date of first documented progression, assessed up to 60 months	a tumor volume equal to or less than the tumor volume at start of radiotherapy

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan