SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

NCT06987370 | Recruiting

• 1 other identifier: SDZLEC2025-076-03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Metastases in Subjects With Advanced Cancer

Keywords

bone metastases; bone metastases with soft tissue; SFRT; SCART

Outcome Measures

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.

  1 year

Secondary Outcomes (3)

• The pain relief rate

  1 year

• Local control rate

  1 year

• Adverse event incidence (Safety)

  1 year

Study Arms (2)

SFRT/SCART GROUP

EXPERIMENTAL

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 Radiotherapy (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.

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

Conventional Radiotherapy (CRT) Group

ACTIVE COMPARATOR

The conventional radiotherapy group, that is, the control group, delineated the target areas in accordance with the consensus guidelines on the definition of target volumes in spinal stereotactic radiosurgery by the International Spine Radiosurgery Consortium and other relevant guidelines according to the location of bone metastases, and administered conventional external beam radiotherapy with a dose of 30 Gy in 10 fractions to the bone metastasis lesions.

Radiation: Conventional Radiotherapy (CRT)

Interventions

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.

Also known as: CRT group

Conventional Radiotherapy (CRT) Group

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.

Also known as: SCART (Stereotactic Core Ablative Radiation Therapy ) /SFRT（Spatially Fractionated Radiation Therapy ）, SCART/SFRT group

SFRT/SCART GROUP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Sign a written informed consent form before implementing any trial-related procedures; 2. Male or female, aged 18 years or above and 75 years or below; 3. Have a histopathologically confirmed single primary tumor (patients with a pathological diagnosis of small cell carcinoma or undifferentiated carcinoma are excluded); 4. ECOG PS 0-2; 5. Have at least one target lesion: bone metastasis with a soft tissue mass confirmed by CT or MRI. The shortest diameter of the soft tissue is greater than 30mm; 6. The number of metastatic lesions is ≤ 5 and the number of metastatic organs is ≤ 3; 7. The expected survival time is ≥ 3 months; 8. The main organ functions are normal (within 14 days before enrollment), that is, the following criteria are met:
• The blood routine examination criteria should meet:
• Hemoglobin (HB) ≥ 90g/L;
• Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L;
• Platelet count (PLT) ≥ 75×10⁹/L;
• There is no functional organic disease, and the following criteria should be met:
• 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;
• Serum creatinine level Cr ≤ 1.5×ULN (if the serum creatinine is elevated, a 24-hour urine collection is required, except for those with a 24-hour creatinine clearance rate \> 50ml/min);
• Urine protein \< 2+. If the test strip result is ≥ 2+, the 24-hour urine protein must be \< 2g, or the urine protein-to-creatinine ratio (UPC) must be \< 2;
• International normalized ratio (INR) and activated partial thromboplastin time (APTT): ≤ 1.5×ULN;

You may not qualify if:

• Pathological fracture confirmed by CT or MR.
• Prior radiotherapy to the target lesion.
• Pregnant or lactating women.
• Acute infection or other serious underlying diseases.
• Obvious history of neurological and mental diseases, including dementia that may affect the ability to understand and give informed consent.
• History or evidence of diseases, treatments or abnormal laboratory test values that may interfere with the test results and prevent the subject from participating in the study throughout the whole process, or other situations that the researcher deems inappropriate for enrollment. The researcher believes that there are other potential risks that make the subject unsuitable for participating in this study.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

RECRUITING

Related Publications (8)

• Dunne EM, Sahgal A, Lo SS, Bergman A, Kosztyla R, Dea N, Chang EL, Chang UK, Chao ST, Faruqi S, Ghia AJ, Redmond KJ, Soltys SG, Liu MC. International consensus recommendations for target volume delineation specific to sacral metastases and spinal stereotactic body radiation therapy (SBRT). Radiother Oncol. 2020 Apr;145:21-29. doi: 10.1016/j.radonc.2019.11.026. Epub 2019 Dec 23.

  PMID: 31874346 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Nguyen TK, Chin L, Sahgal A, Dagan R, Eppinga W, Guckenberger M, Kim JH, Lo SS, Redmond KJ, Siva S, Stish BJ, Chan R, Lawrence L, Lau A, Tseng CL. International Multi-institutional Patterns of Contouring Practice and Clinical Target Volume Recommendations for Stereotactic Body Radiation Therapy for Non-Spine Bone Metastases. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):351-360. doi: 10.1016/j.ijrobp.2021.09.004. Epub 2021 Sep 9.

  PMID: 34509549 BACKGROUND

• Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.

  PMID: 22608954 BACKGROUND

• Wu X, Perez NC, Zheng Y, Li X, Jiang L, Amendola BE, Xu B, Mayr NA, Lu JJ, Hatoum GF, Zhang H, Chang SX, Griffin RJ, Guha C. The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). Radiat Res. 2020 Dec 1;194(6):737-746. doi: 10.1667/RADE-20-00066.1.

  PMID: 33064814 BACKGROUND

• Yang J, Lu Q, Qi W, Kolb RD, Wang L, Li Y, Li S, Lin Y, Liu J, Mourad W, MirkhaghaniHaghighi F, Slavisa T, Wu X, You WC, Yang E, Hanlon A, Zhu A, Yan W. Stereotactic central/core ablative radiation therapy: results of a phase I study of a novel strategy to treat bulky tumor. Front Oncol. 2024 May 24;14:1364627. doi: 10.3389/fonc.2024.1364627. eCollection 2024.

  PMID: 38854732 BACKGROUND

• Jung IH, Yoon SM, Kwak J, Park JH, Song SY, Lee SW, Ahn SD, Choi EK, Kim JH. High-dose radiotherapy is associated with better local control of bone metastasis from hepatocellular carcinoma. Oncotarget. 2017 Feb 28;8(9):15182-15192. doi: 10.18632/oncotarget.14858.

  PMID: 28146433 BACKGROUND

• Kou Y, Xu K, Zhu K, Jiang S, Feng R, Dou X, Xu L, Zhang X, Shi F, Liu X, Gong Z, Yue J. 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. Precis Radiat Oncol. 2025 Dec 19;9(4):260-265. doi: 10.1002/pro6.70036. eCollection 2025 Dec.

  PMID: 41477287 DERIVED

Study Officials

• Jinbo Yue, Doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbo Yue, Doctor

CONTACT

0531-67626442; jbyue@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directorof Radiation Oncology Department

Model Details: This study intends to recruit 90 patients with bone metastases with soft tissue formation and randomly assign them to the experimental group and the group in a ratio of 2:1. The experimental group will be treated with either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Adaptive Radiotherapy (SCART) for the bone metastatic lesions (8-12 Gy in 1 fraction for vertices/SCART- treatment volume in the soft tissue lesions followed by 25-40 Gy in 5 fractions for the whole bone metastatic lesions). The control group will receive conventional external radiotherapy with a dose of 30 Gy in 10 fractions.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)