NCT05943119招募中2 期
Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
Centre Francois Baclesse3 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年3月11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
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
研究概览
简要总结
The patient is randomized to one of the following groups:
- Experimental group: Radiotherapy in painting dose on histoscannographic mapping
- Control group: standard pan-sinus radiotherapy
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
- •Patients >18 years of age
- •Patient with a histologically confirmed malignant tumor of the sinuses, any histological type except melanoma, lymphoma, mesenchymal tumors (sarcoma)
- •Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy
- •Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)
- •Signature of informed consent prior to any specific study procedure
- •Subject affiliated to a social security system
排除标准
- •Patient with not operated in place tumor
- •Patient with distant metastases
- •Patient treated with neoadjuvant chemotherapy
- •Pregnant or breast-feeding woman or absence of contraception during genital activity
- •History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years.
- •Simultaneous participation in another therapeutic clinical trial
- •Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent.
- •Patients unable to undergo trial monitoring for geographical, social or psychopathological reasons
研究组 & 干预措施
Control group: standard pan-sinus Radiotherapy
Active Comparator
干预措施: Standard pan-sinusal Radiotherapy (Radiation)
Experimental group: Radiotherapy in painting dose on histoscannographic mapping
Experimental
干预措施: Radiotherapy in painting dose on histoscannographic mapping (Radiation)
结局指标
主要结局
Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
时间窗: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
Proportion of patients who do not develop radiation-induced mucosal, ocular, auditory, endocrine and/or nervous system toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
次要结局
未报告次要终点
研究者
研究点 (3)
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