A Phase II Study of Intensity Modulated Radiotherapy (IMRT) for Patients With Primary Bone and Soft Tissue Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 36
- 主要终点
- Cohort 1 (limb soft tissue sarcomas): The rate of grade 2 or more late soft tissue fibrosis at 2 years following radiotherapy as assessed by RTOG late radiation morbidity criteria.
研究概览
简要总结
IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical outcomes.
Cohort 1 of the trial is now closed to recruitment.
详细描述
IMRiS is a prospective multicentre phase II trial of Intensity Modulated Radiotherapy (IMRT). The trial is aiming to evaluate the role of intensity modulated radiotherapy (IMRT) in soft tissue and bone sarcomas. Three separate sarcoma cohorts will be studied and will be analysed separately. Patients will be enrolled in one of three cohorts depending on the type of sarcoma they have:
Cohort 1- Patients with Limb/limb girdle soft tissue sarcoma receiving (neo)-adjuvant radiotherapy. (closed to recruitment)
Cohort 2- Patients with Ewing sarcoma of the spine/pelvis receiving definitive radical or (neo)-adjuvant radiotherapy.
Cohort 3- Patients with non-Ewing primary bone sarcomas of the spine/pelvis receiving definitive radical or adjuvant radiotherapy.
Dose schedules for each Cohort have been indicated in the Trial Arm description.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven soft tissue sarcoma of the upper or lower limb or limb girdle (Cohort 1), OR,
- •Ewing sarcoma of bone arising in the pelvis or spine (Cohort 2) , OR,
- •High grade primary bone sarcoma (non-Ewing) or Chordoma arising in the pelvis/spine (Cohort 3)
- •Patients requiring (neo)adjuvant or definitive radical radiotherapy
- •WHO performance status 0-2
- •Patients aged 16 years or more
- •Patients fit enough to undergo radiotherapy treatment and willing to attend follow up visits as per protocol
- •Women of child-bearing potential must have a negative pregnancy test prior to trial entry. Female patients of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods, which must be continued for 3 months after completion of treatment.
- •Capable of giving written informed consent
排除标准
- •Previous radiotherapy to the same site
- •Patients receiving concurrent chemotherapy with radiotherapy (neo-adjuvant chemotherapy prior to radiotherapy is permitted.
- •Patient with bone sarcomas eligible for proton beam radiotherapy; N.B. if a patient is not to have PBRT for whatever reason, they may be considered for IMRiS.
- •Paediatric type alveolar or embryonal rhabdomyosarcomas
- •Pregnancy (Women of child-bearing potential must have a negative pregnancy test prior to trial entry. Female patients of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods, which must be continued for 3 months after completion of treatment
- •Patients with concurrent or previous malignancy that could compromise assessment of the primary and secondary endpoints of the trial; these cases must be discussed with UCL CTC prior to the patient being approached.
结局指标
主要结局
Cohort 1 (limb soft tissue sarcomas): The rate of grade 2 or more late soft tissue fibrosis at 2 years following radiotherapy as assessed by RTOG late radiation morbidity criteria.
时间窗: From date of registration until 2 years after date of registration.
Late toxicity assessment measured using RTOG late radiation morbidity criteria.
Cohort 3 (Non-Ewing's primary bone sarcomas of the spine/pelvis): The proportion of patients in whom 80% of the planPTV receives 95% of the optimal prescription dose.
时间窗: Upon completion of IMRT treatment
Cohort 3 (Non-Ewing's primary bone sarcomas of the spine/pelvis): The proportion of patients in whom 80% of the planPTV receives 95% of the optimal prescription dose.
Cohorts 2 (Ewing's sarcoma of the spine/pelvis): The proportion of patients in whom 90% of the planPTV receives 95% of the optimal prescription dose.
时间窗: Upon completion of IMRT treatment
Cohorts 2 (Ewing's sarcoma of the spine/pelvis): The proportion of patients in whom 90% of the planPTV receives 95% of the optimal prescription dose.
次要结局
- Time to local disease progression (Cohorts 2 and 3, for definitive radical RT)(From date of registration to date of documented progression (assessed up to 3 years from date of registration))
- Patient reported Quality of life (QOL) - (All cohorts)(Timepoints- Baseline, 1 year and 2 year post treatment)
- Overall survival (All Cohorts)(From date of registration to date of death or date of last follow-up assessment (assessed up to 3 years from date of registration))
- Acute RT toxicity - (For all cohorts)(From date of registration up to 90 days after date of registration)
- Late RT toxicity - (For all cohorts)(From Day 91 after date of registration up to 3 years after date of registration)
- Disease free survival (All Cohorts)(The start date for analysis will be the date of registration. From date of registration to date of documented disease progression assessed up to 3 years from date of registration)
- Time to local tumour recurrence (All Cohorts, for adjuvant RT)(From date of registration to date of documented recurrence within the irradiated site (assessed up to 3 years from date of registration))
- Patient reported limb function (Cohort 1 only)(At timepoints - Baseline, 1 year and 2 years post Treatment)
- Wound complications within 120 days of surgery (Cohort 1 only)(From date of definitive surgery until 120 days post surgery)
- Response by RECIST 1.1 (Cohorts 2 and 3, for definitive radical RT)(From date of registration to date of documented progression (assessed up to 3 years from date of registration))
- For individual plans (cohort 2 & 3)(Upon completion of IMRT treatment.)