Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-01 @ 9:49 PM
Study NCT ID:
NCT06980259
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Study Overview
Official Title:
Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma:A Multicenter，Prospective, Phase II, Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0), and quality of life (QoL, assessed by EORTC QLQ-C30). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.
Detailed Description:
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to systematically compare the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) versus Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). STS is a malignant tumor with low radiosensitivity, and CRT yields limited objective response rates (ORR) and local control rates (LC). The study employs Intensity-Modulated Radiation Therapy (IMRT), Intensity-Modulated Proton Therapy (IMPT), or Volumetric Modulated Arc Therapy (VMAT) techniques. CRT is administered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT builds on CRT at 3.0 Gy per fraction for 15-20 fractions, supplemented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and stimulate potential immune responses.
A total of 106 patients will be enrolled and randomized 1:1 into the SFRT and CRT arms (53 patients per arm). The primary endpoint is the ORR of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year LC of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0).
Eligibility criteria include patients aged 18-70 years, ECOG performance status ≤2, and an expected survival of ≥3 months, excluding those with secondary primary tumors or severe organ dysfunction. Comprehensive baseline assessments (imaging, pathology, and laboratory tests) are conducted before treatment. Toxicity is monitored weekly during treatment, with ≥grade 3 toxicities prompting treatment suspension. Efficacy evaluations are performed at 3, 6, 9, and 12 months post-radiotherapy, with follow-up scheduled every 3 months in the first year, every 6 months in the second year, and annually thereafter. Statistical analysis is based on a one-sided α=0.05 and β=0.8, anticipating an ORR of 40% for SFRT compared to 15% for CRT.
Through its multicenter design and rigorous evaluation, this study aims to validate whether SFRT can improve ORR in STS, providing scientific evidence to optimize radiotherapy strategies, enhance patient prognosis, and improve QoL. Additionally, it seeks to offer insights into the treatment of other radioresistant tumors.
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to systematically compare the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) versus Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). STS is a malignant tumor with low radiosensitivity, and CRT yields limited objective response rates (ORR) and local control rates (LC). The study employs Intensity-Modulated Radiation Therapy (IMRT), Intensity-Modulated Proton Therapy (IMPT), or Volumetric Modulated Arc Therapy (VMAT) techniques. CRT is administered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT builds on CRT at 3.0 Gy per fraction for 15-20 fractions, supplemented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and stimulate potential immune responses.
A total of 106 patients will be enrolled and randomized 1:1 into the SFRT and CRT arms (53 patients per arm). The primary endpoint is the ORR of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year LC of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0).
Eligibility criteria include patients aged 18-70 years, ECOG performance status ≤2, and an expected survival of ≥3 months, excluding those with secondary primary tumors or severe organ dysfunction. Comprehensive baseline assessments (imaging, pathology, and laboratory tests) are conducted before treatment. Toxicity is monitored weekly during treatment, with ≥grade 3 toxicities prompting treatment suspension. Efficacy evaluations are performed at 3, 6, 9, and 12 months post-radiotherapy, with follow-up scheduled every 3 months in the first year, every 6 months in the second year, and annually thereafter. Statistical analysis is based on a one-sided α=0.05 and β=0.8, anticipating an ORR of 40% for SFRT compared to 15% for CRT.
Through its multicenter design and rigorous evaluation, this study aims to validate whether SFRT can improve ORR in STS, providing scientific evidence to optimize radiotherapy strategies, enhance patient prognosis, and improve QoL. Additionally, it seeks to offer insights into the treatment of other radioresistant tumors.
A total of 106 patients will be enrolled and randomized 1:1 into the SFRT and CRT arms (53 patients per arm). The primary endpoint is the ORR of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year LC of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0).
Eligibility criteria include patients aged 18-70 years, ECOG performance status ≤2, and an expected survival of ≥3 months, excluding those with secondary primary tumors or severe organ dysfunction. Comprehensive baseline assessments (imaging, pathology, and laboratory tests) are conducted before treatment. Toxicity is monitored weekly during treatment, with ≥grade 3 toxicities prompting treatment suspension. Efficacy evaluations are performed at 3, 6, 9, and 12 months post-radiotherapy, with follow-up scheduled every 3 months in the first year, every 6 months in the second year, and annually thereafter. Statistical analysis is based on a one-sided α=0.05 and β=0.8, anticipating an ORR of 40% for SFRT compared to 15% for CRT.
Through its multicenter design and rigorous evaluation, this study aims to validate whether SFRT can improve ORR in STS, providing scientific evidence to optimize radiotherapy strategies, enhance patient prognosis, and improve QoL. Additionally, it seeks to offer insights into the treatment of other radioresistant tumors.
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to systematically compare the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) versus Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). STS is a malignant tumor with low radiosensitivity, and CRT yields limited objective response rates (ORR) and local control rates (LC). The study employs Intensity-Modulated Radiation Therapy (IMRT), Intensity-Modulated Proton Therapy (IMPT), or Volumetric Modulated Arc Therapy (VMAT) techniques. CRT is administered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT builds on CRT at 3.0 Gy per fraction for 15-20 fractions, supplemented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and stimulate potential immune responses.
A total of 106 patients will be enrolled and randomized 1:1 into the SFRT and CRT arms (53 patients per arm). The primary endpoint is the ORR of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year LC of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0).
Eligibility criteria include patients aged 18-70 years, ECOG performance status ≤2, and an expected survival of ≥3 months, excluding those with secondary primary tumors or severe organ dysfunction. Comprehensive baseline assessments (imaging, pathology, and laboratory tests) are conducted before treatment. Toxicity is monitored weekly during treatment, with ≥grade 3 toxicities prompting treatment suspension. Efficacy evaluations are performed at 3, 6, 9, and 12 months post-radiotherapy, with follow-up scheduled every 3 months in the first year, every 6 months in the second year, and annually thereafter. Statistical analysis is based on a one-sided α=0.05 and β=0.8, anticipating an ORR of 40% for SFRT compared to 15% for CRT.
Through its multicenter design and rigorous evaluation, this study aims to validate whether SFRT can improve ORR in STS, providing scientific evidence to optimize radiotherapy strategies, enhance patient prognosis, and improve QoL. Additionally, it seeks to offer insights into the treatment of other radioresistant tumors.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: