Phase 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT)
研究概览
简要总结
This is phase II randomized, multicenter study of treatment with L-TC and preoperative HFRT in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity.
Eligible patients will be randomly assigned 2:1 to receive a preoperative HFRT alone (Arm A) or L-TC with preoperative HFRT (Arm B).
详细描述
This is a non-comparative phase II trial (comparison is made regarding a reference, not 2 between 2 proportions). Considering the wide confidence interval retrieved in literature regarding pCR value with HFRT, pCR value used in the sample size calculation and taken from the literature must be included in the 95% CI of the pCR from the control group.
The PRACTISS trial aims to improve treatment outcomes for patients with extremity STS by incorporating Liposomal Transcrocetin (L-TC) with Hypofractionated Radiotherapy (HFRT). L-TC is designed to enhance tumor oxygenation, addressing hypoxia-a significant factor contributing to radioresistance. By reoxygenating tumor cells, L-TC may improve radiosensitivity, increasing the efficacy of radiotherapy and leading to higher rates of pathological complete response (pCR) before surgery. Achieving a higher pCR is associated with better long-term outcomes and reduced recurrence rates. Additionally, the use of HFRT reduces the overall treatment schedule compared to conventional radiotherapy, minimizing the treatment burden for patients and potentially improving their quality of life while maintaining treatment effectiveness.
L-TC 300 mg QD, administered as intravenous infusion over 90 minutes, at a fixed dose of 300 mg daily before each HFRT fraction, for a total of 5 days corresponding to the planned five daily HFRT fractions. The intravenous infusion should start 120 minutes before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Localized or locally advanced soft tissue sarcoma of extremity proven by biopsy histological grade 2 and
- •Pathological expert proof-reading in reference centers
- •HFRT and surgery planned (regardless the potential inclusion in this trial) as decided in a multidisciplinary tumor board, in reference centre (European Society for Medical Oncology (ESMO) guideline 2021)
- •R0 surgery is feasible, in reference centers
- •Pre-biopsy MRI available
- •Performance status of 0-2 and life expectancy of at least 6 months
排除标准
- •Patient who cannot undergo MRI
- •Patients with localized or locally advanced soft tissue sarcoma of extremity proven by biopsy with histological grade 1
- •Previous radiation in the area
- •Woman who is pregnant or breastfeeding
- •Soft tissue sarcoma developed in irradiated area.
- •Patients with myxoid liposarcoma, embryonal or alveolar rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, angiosarcoma, primitive neuroectodermal tumor, desmoid-type fibromatosis, or dermatofibrosarcoma protuberans
- •Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years.
研究组 & 干预措施
Hypofractionated radiotherapy alone
HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
干预措施: HFRT alone (Radiation)
Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)
L-TC as an IV infusion over 90 minutes at a fixed dose of 300 mg daily before each HFRT fraction, for a total of 5 days corresponding to the planned five daily HFRT fractions. The intravenous infusion should begin 2 hours before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion. + HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
干预措施: Administration of L-TC (Drug)
结局指标
主要结局
Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT)
时间窗: At surgery (Between 4 and 8 weeks after the end of radiotherapy)
Pathological complete response rate (pCR): defined as the presence of \< 10% residual malignant viable cells.
次要结局
- Evaluation of the acute tolerance o f L-TC(Up to day 5 (every day during the treatment))
- Evaluation of the late tolerance o f L-TC(Up to day 28 after the end of treatment.)
- Evaluation of the acute tolerance of radiotherapy(Up to day 5 (every day during the treatment))
- Evaluation of the late tolerance of radiotherapy(at 4 months after surgery, and at 12, 18, 24, 36 and 60 months)
- Evaluation of tumour necrosis(At surgery (Between 4 and 8 weeks after the end of radiotherapy))
- Evaluation of the radiological response(at screening and before surgery)
- Proportion of patients with R0 resection(At surgery)
- Evaluation of the Local Progression-Free Survival (L-PFS)(at 12, 24, 36 and 60 months.)
- Evaluation of the Distant Progression-Free Survival (D-PFS)(at 12, 24, 36 and 60 months.)
- Evaluation of the Overall Survival (OS)(at 12, 24, 36 and 60 months)
- Evaluation of the Quality of Life (QoL)(at the inclusion (baseline) and every 4 months the two first years and then every 6 months the next three years)