2024-513972-16-00招募中3 期
Phase III randomized trial comparating concomittant administration of radiotherapy with cisplatin versus radiotherapy only for treatment of sinuses tumors and salivary glands (SANTAL)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 342
- 试验地点
- 31
- 主要终点
- Progression-free survival
研究概览
简要总结
To Compare progression free survival (PFS) between the 2 treatment arms: RT only versus RT-CT as adjuvant therapy in surgical patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Resected tumors of the sinuses or salivary glands: T3-4 N0 or T1-4 N1-3 or T1-2 N0 with invaded edges or positive margins (< 5 mm) or Unresectable or inoperable tumors of the sinuses or salivary glands
- •Carcinomas of the main salivary glands (parotid, submandibular or sublingual glands) and accessories or Malignant tumors of the sinuses with any histological type except melanomas, lymphomas, mesenchymal tumors (sarcoma type), squamous cell carcinomas and nasopharyngeal carcinomas of type 1, 2,
- •Age ≥ 18 years
- •Performance index according to the World Health Organization (WHO) criteria from 0 to 2
- •For patients ≥ 70 years, the G8 questionnaire score must be > 14 with no falls noted in the previous 12 months or presenting a geriatric assessment compatible with the administration of chemotherapy
- •Estimated life expectancy greater than or equal to 6 months
排除标准
- •History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the pathology concerned
- •Synchronous metastases
- •Contraindications to the administration of cisplatin or carboplatin
- •Other cancer, except in situ cervical cancer, skin carcinoma (except melanoma) or cancer controlled for more than 5 years
结局指标
主要结局
Progression-free survival
Progression-free survival
次要结局
- Overall survival
- Quality of life
- Time to locoregional progression
- Time to distance progression
- Rate of acute toxicity grade ≥ 3
- Rate of late toxicities of grade ≥ 3
- Prognostic criteria
研究者
Dr François Regis FERRAND
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (31)
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