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SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

ConditionBone Metastases in Subjects With Advanced Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Cancer Hospital and Institute

About this trial

This is a randomized, controlled, prospective phase II, two-arm clinical study designed to evaluate the efficacy and safety of using either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Ablative Radiotherapy (SCART) for treating the soft tissue components of malignant bone metastases. The study plans to enroll 90 patients with bone metastases accompanied by soft tissue formation, who will be randomized in a 2:1 ratio to the SFRT/SCART group or the conventional radiotherapy (CRT) group.The primary endpoint is the objective response rate (ORR). Tumor response to treatment will be assessed every 12 weeks (±7 days) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary endpoints include pain relief rate, progression-free survival (PFS), and safety. In addition, adverse events (AEs) will be monitored throughout the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hemoglobin (HB) ≥ 90g/L;

Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L;

Platelet count (PLT) ≥ 75×10⁹/L;

When there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, alkaline phosphatase (ALP) ≤ 3× ULN; when there is liver metastasis, ALT and AST ≤ 5× ULN, serum total bilirubin ≤ 3× ULN, and alkaline phosphatase (ALP) ≤ 5× ULN;

Disqualifiers

Pathological fracture confirmed by CT or MR.

Prior radiotherapy to the target lesion.

Pregnant or lactating women.

Acute infection or other serious underlying diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Radiotherapy (CRT)

    Radiation

    The conventional radiotherapy group, that is, the control group, administering conventional external beam radiotherapy with a dose of 30 Gy in 10 fractions to the bone metastasis lesions.

  • SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）

    Radiation

    Stereotactic Central Ablative Radiotherapy (SCART): When using SCART to treat bone metastases with associated soft tissue components, the gross tumor volume (GTV) of the bone metastases must be accurately delineated according to the guidelines. The GTV are contracted to derive the SCART-Treatment Volume (STV). An initial dose of 8-12 Gy in a single fraction is delivered to the STV, followed by a dose of 25-40 Gy in 5 fractions to the clinical target volume (CTV). Spatially Fractionated Radiation Therapy (SFRT): The GTV are reduced to form a "LATTICE" target area. Several vertices are uniformly contoured along the edges of the "LATTICE." A dose of 8-12 Gy in a single fraction is delivered to the vertices, followed by a dose of 25-40 Gy in 5 fractions to the CTV.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: SFRT/SCART GROUPExperimental treatment 1 intervention
Group B: Conventional Radiotherapy (CRT) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Defined as the proportion of patients whose tumor size decreases (partial response) or disappears (complete response) after radiation based on RECIST 1.1. (CR, complete disappearance of the lesion) or partial response (PR, ≥30% reduction in lesion diameter sum) at 3, 6, 9, and 12 months post-radiotherapy, evaluated according to RECIST 1.1.

Time frame
1 year

Secondary outcomes

1

The pain relief rate

The NRS score is used as an indicator of the treatment response. Complete remission is defined as the absence of pain three months after radiotherapy. Partial remission is defined as the pain score being at least 2 points lower than the initial score (or the daily dosage of narcotic drugs decreasing by more than 20%). The stable state is defined as the change in the pain score not exceeding 1 point (or the change in the daily dosage of narcotic drugs not exceeding 10%). A progressive response is defined as the pain score being at least 2 points higher than the initial score (or the daily dosage of narcotic drugs increasing by more than 20%).

Time frame
1 year
2

Local control rate

Local control rate is defined as the time from the start of radiotherapy to either progression of the target lesion (assessed per RECIST 1.1 criteria) or patient death from any cause, whichever occurs first.

Time frame
1 year
3

Adverse event incidence (Safety)

Treatment-related adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE 5.0).

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov
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