Efficacy and Toxicity of SCART

April 7, 2025 updated by: Hao-Shen Cheng, Taichung Veterans General Hospital

Efficacy and Toxicity of Stereotactic Central/Core Ablative Radiation Therapy (SCART) - A Prospective Observational Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control (LC)
Time Frame: 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
From date of radiotherapy until the date of first documented progression, assessed up to 60 months
Progression-Free Survival (PFS)
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 8, 2025

Study Completion (Actual)

April 8, 2025

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VGHTCCTC_SCART001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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