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NCT06987370

SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

Recruiting now NA Last updated 8 July 2025
What this trial tests

NA trial testing Conventional Radiotherapy (CRT) in Bone Metastases in Subjects With Advanced Cancer in 90 participants. Currently enrolling.

Timeline
1 June 2025
Primary endpoint
30 November 2027
30 November 2027

Quick facts

Lead sponsorShandong Cancer Hospital and Institute
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment90
Start date1 June 2025
Primary completion30 November 2027
Estimated completion30 November 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shandong Cancer Hospital and Institute

Who can join

Adults 18 to 75, any sex, with Bone Metastases in Subjects With Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and safety evaluation of radiotherapy approach based on spatially fractionated radiotherapy and stereotactic core ablative radiation therapy technologies for bone metastatic malignant tumors with soft tissue formation: A randomized controlled phase II trial.
    Kou Y, Xu K, Zhu K, Jiang S, et al · · 2025 · PMID 41477287 · DOI 10.1002/pro6.70036

Verify or expand the search:

Other recruiting trials for Bone Metastases in Subjects With Advanced Cancer

Currently open trials in the same condition.

Other Shandong Cancer Hospital and Institute trials

Trials by the same sponsor.

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Data sources for this page

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