Tumor Size Greater Than or Equal to 5 cm
Conditions
Keywords
Bulky tumor, Palliative radiotherapy, Stereotactic Central/Core Ablative Radiation Therapy, Efficacy, Toxicity
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.
Interventions
RADIATIONStereotactic 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.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Taiwan
Outcome results
None listed