NCT06464198招募中不适用
Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Creation of a database
研究概览
简要总结
This is a prospective registry study based on a standard therapy concept for postoperative simultaneous radiochemotherapy established in Erlangen and elsewhere. The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. Patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Salivary gland carcinomas of the major and minor salivary glands of the head and neck region
- •High-grade histology
- •Successful oncological resection with curative intent
- •pT3-4 or pN1-3 or Pn1(perineural sheath infiltration) or pT1-2 with scarce or positive resection margin
- •Indication for postoperative combined radiochemotherapy (guideline-compliant radiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 Gy (depending on resection status), common chemotherapy regimens: Paclitaxel 135mg/m² KOF d1 and cisplatin 33mg/m² KOF d1-3, q d22 or paclitaxel 135mg/m² KOF d1, carboplatin AUC 1.5 KOF d1-3 or paclitaxel 50mg/m² KOF, carboplatin AUC2 d1,8,15, q d22 or paclitaxel 50mg/m²KOF and cisplatin 30mg/m² KOF d1,8,15, q d22, 4 cycles each).
- •Patient age ≥18 years
- •WHO performance score ≤ 1
- •Signed patient information/consent form
排除标准
- •Distant metastases
- •Other cancer in the last 5 years prior to study inclusion (with the exception of: adequately treated skin cancer (except melanoma) or lentigo maligno or adequately treated carcinoma in situ, in each case without evidence of active disease).
- •Previous chemotherapy or radiotherapy for salivary gland carcinoma
- •Previous radiotherapy in the head and neck area
- •Pre-existing uncontrolled disease that constitutes a contraindication to simultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardial infarction within the last 6 months before the start of therapy, congestive heart failure, heart disease with New York Heart Association (NYHA) III or IV classification, active and therapy-resistant infection, pre-existing or concomitant immunodeficiency syndrome)
- •Pregnancy and breastfeeding
- •Fertile patients who cannot ensure effective contraception during and up to six months after combination therapy
研究组 & 干预措施
Patient
Patients with locally advanced high-grade salivary gland carcinoma after oncological resection
干预措施: simultaneous postoperative radiochemotherapy (Procedure)
结局指标
主要结局
Creation of a database
时间窗: 63 months (12 weeks therapy plus 5 years follow-up)
Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.
次要结局
- Observation of Disease-specific survival(63 months (12 weeks therapy plus 5 years follow-up))
- Observation of Survival free of distant metastases(63 months (12 weeks therapy plus 5 years follow-up))
- Observation of Disease-free survival(63 months (12 weeks therapy plus 5 years follow-up))
- Observation of Overall survival(63 months (12 weeks therapy plus 5 years follow-up))
- Observation of Local recurrence-free survival(63 months (12 weeks therapy plus 5 years follow-up))
- Determination of toxicity(63 months (12 weeks therapy plus 5 years follow-up))
研究者
研究点 (1)
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