Efficacy and Toxicity of SCART

Taichung Veterans General Hospital

Status: Withdrawn

Conditions: Tumor Size Greater Than or Equal to 5 cm

Treatments: Radiation: Stereotactic Central/Core Ablative Radiation Therapy (SCART)

Study type: Interventional

Funder types: Other

Identifiers

NCT06341257

VGHTCCTC_SCART001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SCART

Experimental group

Description:

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.

Treatment:

Radiation: Stereotactic Central/Core Ablative Radiation Therapy (SCART)