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Efficacy and Toxicity of SCART

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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 details

Tumor Size Greater Than or Equal to 5 cm

NCT06341257

Taichung Veterans General Hospital

13 April 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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