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A randomized phase II study: Evaluating the efficacy of innovative stereotactic body radiotherapy (SCART) versus conventional radiotherapy (CRT) in massive metastatic cancer.

A randomized phase II study: Evaluating the efficacy of innovative stereotactic body radiotherapy (SCART) versus conventional radiotherapy (CRT) in massive metastatic cancer.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122474
Enrollment
Unknown
Registered
2026-04-14
Start date
2023-10-16
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

SCART group:Innovative Stereotactic Body External Radiation Therapy Group: The dose level is 21Gy delivered in 3 fractions, while maintaining a margin dose of 5Gy per fraction around the entire tumor
Control group:Radiotherapy will be delivered using external beam radiation, employing 2D/conventional techniques, 3D conformal therapy, intensity-modulated radiation therapy (IMRT), stereotactic radio

Sponsors

Foshan Fosun Chancheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient has been pathologically confirmed to have cancer through tumor biopsy. 2. The patient is diagnosed with stage IV cancer according to the American Joint Committee on Cancer (AJCC) 7th edition, with a minimum size of 5cm at the largest cross-sectional area. 3. One or more metastatic lesions (not site-specific). Metastatic lesions are counted as follows: lesions are counted by different organs (including satellite nodules). 4. The patient has non-stage IV cancer, but with tumor dimensions of 5cm in any continuous dimension, is not considered a surgical candidate and is not suitable for final chemotherapy. 5. The patient has an ECOG performance status of = 18 years old. 8. The patient has signed an informed consent form. 9. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier methods; abstinence) during the study and for six (6) months after discontinuing the study drug. Women of childbearing potential are defined as those who have had a menstrual period in the past 12 months and have not undergone tubal ligation, hysterectomy, or bilateral oophorectomy. If a woman becomes pregnant or suspects she is pregnant during her participation in this study, she should notify her attending physician immediately. If the patient is male, he agrees to use effective contraception or abstinence during the study and for six (6) months after discontinuing the study drug.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of uncontrolled angina, arrhythmias, or congestive heart failure. 2. Patients with a history of malignant pleural effusion are ineligible.Researchers hold the view that pleural effusion which is too small to perform diagnostic thoracentesis is permissible. 3. Patients who are pregnant (if applicable, confirmed by serum b-HCG) or lactating. 4. Patients must not have any comorbid conditions with a life expectancy of <= 6 months, or any uncontrolled intermittent diseases, including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or any psychiatric disorders/social situations that would limit compliance with study requirements. 5. Exclusion of patients with brain metastases from enrollment.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Blood routine test;C-reactive protein(CRP);Lactate Dehydrogenase;T cells, B cells, and Natural Killer cells (CD3\CD4\CD8\CD19\NK);

Secondary

MeasureTime frame
Th1/Th2 cytokines (IL2/IL4/IL6/IL10);

Countries

China

Contacts

Public ContactYang Jun

Foshan Fosun Chancheng Hospital

Junbme@yahoo.com+86 185 1168 0543

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026