Efficacy and Toxicity of SCART

NCT ID: NCT06341257

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-04-08

Brief Summary

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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.

Detailed Description

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Conditions

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Tumor Size Greater Than or Equal to 5 cm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stereotactic Central/Core Ablative Radiation Therapy (SCART)

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hao-Shen Cheng

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 19997074 (View on PubMed)

Other Identifiers

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VGHTCCTC_SCART001

Identifier Type: -

Identifier Source: org_study_id

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