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Trial Title:
Efficacy and Toxicity of SCART
NCT ID:
NCT06341257
Condition:
Tumor Size Greater Than or Equal to 5 cm
Conditions: Keywords:
Bulky tumor
Palliative radiotherapy
Stereotactic Central/Core Ablative Radiation Therapy
Efficacy
Toxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Central/Core Ablative Radiation Therapy (SCART)
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.
Arm group label:
SCART
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
407
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Hao-Shen Cheng, MD
Phone:
886975871151
Email:
mark89050921@gmail.com
Start date:
January 1, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Taichung Veterans General Hospital
Agency class:
Other
Source:
Taichung Veterans General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341257
