跳至主要内容
临床试验/NCT06436612
NCT06436612招募中2 期

Phase II Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas (MARS Trial)

Jonsson Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月30日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
20
试验地点
2
主要终点
Radiation morbidity at 2 years

研究概览

简要总结

Recent advances in radiation treatment have allowed for higher doses per treatment to be delivered safely. This study plans to use an MRI-guided linear accelerator to deliver the radiation treatment to ensure that the radiation dose is administered to the cancerous tumor, not the vital body organs.

Potential participants with a sarcoma diagnosis will be referred to Radiation Oncology during this study. If the participant is interested in participating in this study, s/he receives radiation treatment daily for 5 consecutive days except for weekends and holidays. Within 12 weeks of completing the radiation therapy, the participant will have the primary tumor surgically removed. The radiation oncology team will follow the patients for 5 years after completing radiation therapy.

详细描述

Each patient will undergo radiation simulation and planning. A custom vac-lok bag, alpha cradle, or equivalent immobilization device will be used. Both CT and MRI simulation will be obtained, which is standard of care for any patient undergoing radiation therapy for soft tissue sarcomas.

The study investigator will be responsible for delineating the gross tumor volume (GTV) using the CT as well as MRI performed as part of staging. Guidelines for contouring will be as per the currently open NRG trial for sarcomas. In general, this may entail expansions by 5-15 mm isotropically, should include any suspicious areas be identified on T2 weighted MRI, and should be cropped to natural anatomic borders. This clinical target volume (CTV) will then be expanded to a planning treatment volume (PTV) using a 3-5 mm expansion.

A prescription dose of 5-6 Gy x 5 fractions (25-30 Gy) will be delivered to at least 95% of the PTV. Stereotactic body radiotherapy (SBRT) and/or intensity modulated radiotherapy (IMRT) planning techniques may be used to minimize radiation dose to nearby organs at risk (OAR) but is not required.

Delineation of normal structures will be performed and verified by the responsible study investigator. The radiation physicist or dosimetrist will optimize the treatment plan prior to approval for treatment. Dose volume histograms (DVH) and normal tissue constraint parameters specified below will be used to judge the plan quality and optimize PTV coverage with OAR sparing prior to approval.

Radiation will be delivered daily for 5 consecutive days with the exception of weekends and holidays. In instances where the radiation treatment week contains a holiday or scheduling availability is limited, two fractions of radiation may be given on the same day providing that the fractions are administered ≥ 6 hours apart (this is considered standard of care treatment).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed sarcoma
  • Primary or recurrent disease involving the abdomen or pelvis
  • Resectable primary lesion
  • Age ≥ 12 years old
  • Karnofsky performance status (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
  • If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented

排除标准

  • Active treatment of a separate malignancy
  • History of prior irradiation to the area targeted for treatment

研究组 & 干预措施

Arm I

Experimental

MRI or CT-guided SBRT will be delivered in the pre-operative setting. Patients will receive 5.0-6.0 Gy x 5 fractions delivered daily.

干预措施: Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy (Radiation)

结局指标

主要结局

Radiation morbidity at 2 years

时间窗: At 2 years

Evaluate the 2 year rate of grade ≥2 radiation morbidity, according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

次要结局

  • Local Control(At 2 years)
  • Progression free survival(At 2 years)
  • Regional Control(At 2 years)
  • Distant metastasis(At 2 years)
  • Overall survival(At 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验