Tumor Size Greater Than or Equal to 5 cmNCT06341257
Efficacy and Toxicity of SCART
A study testing Stereotactic Central/Core Ablative Radiation Therapy (SCART) in people with Tumor Size Greater Than or Equal to 5 cm, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Size Greater Than or Equal to 5 cm
- What is being tested?
- Stereotactic Central/Core Ablative Radiation Therapy (SCART)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Life expectancy less than six months
- Uncontrolled angina, arrythmia, and congestive heart failure
- History of malignant pleural effusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tumor Size Greater Than or Equal to 5 cm
- Being tested
- Stereotactic Central/Core Ablative Radiation Therapy (SCART)
- Keywords
- Bulky tumor, Palliative radiotherapy, Stereotactic Central/Core Ablative Radiation Therapy, Efficacy, Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Central/Core Ablative Radiation Therapy (SCART)Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| SCART | Experimental | 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. Receives: Radiation: Stereotactic Central/Core Ablative Radiation Therapy (SCART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control (LC)
a tumor volume equal to or less than the tumor volume at start of radiotherapy
Measured: From date of radiotherapy until the date of first documented progression, assessed up to 60 months
Progression-Free Survival (PFS)
the time from inclusion to disease progression or death from any cause.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jan 2024
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Why it stopped: No participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumor Size Greater Than or Equal to 5 cmStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao-Shen Cheng, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341257
- Sponsor's protocol ID
- VGHTCCTC_SCART001
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lo SS, Fakiris AJ, Chang EL, Mayr NA, Wang JZ, Papiez L, Teh BS, McGarry RC, Cardenes HR, Timmerman RD. Stereotactic body radiation therapy: a novel treatment modality. Nat Rev Clin Oncol. 2010 Jan;7(1):44-54. doi: 10.1038/nrclinonc.2009.188. Epub 2009 Dec 8.
PubMed 19997074
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Toxicity of Stereotactic Central/Core Ablative Radiation Therapy (SCART) - A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06341257
- Acronym / sponsor ID
- VGHTCCTC_SCART001
- Conditions
- Tumor Size Greater Than or Equal to 5 cm
- Keywords
- Bulky tumor, Palliative radiotherapy, Stereotactic Central/Core Ablative Radiation Therapy, Efficacy, Toxicity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCART | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant
- Life expectancy less than six months
- Uncontrolled angina, arrythmia, and congestive heart failure
- History of malignant pleural effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | SCART |
Primary outcome
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
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 19997074Lo SS, Fakiris AJ, Chang EL, Mayr NA, Wang JZ, Papiez L, Teh BS, McGarry RC, Cardenes HR, Timmerman RD. Stereotactic body radiation therapy: a novel treatment modality. Nat Rev Clin Oncol. 2010 Jan;7(1):44-54. doi: 10.1038/nrclinonc.2009.188. Epub 2009 Dec 8.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Central/Core Ablative Radiation Therapy (SCART) in people with Tumor Size Greater Than or Equal to 5 cm, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (LC) (time frame: From date of radiotherapy until the date of first documented progression, assessed up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.