Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- acute and sub acute toxicity as assessed by CTACE 5.0
研究概览
简要总结
The investigators aim at investigating in a prospective clinical trial whether using a Simoultaneous Integrated Boost of carbon ions treatment planning approach, improving the tumor dose conformation while lowering the unintended dose to the low-risk volume, can significantly reduce the probability of toxicity without affecting Local Control.
详细描述
In photon radiotherapy, Simultaneous integrated boost (SIB)-intensity-modulated radiation therapy (IMRT) with slight hypofractionation in the HR-CTV is the current standard of care, being previously largely adopted in clinical practice and within several prospective clinical trials, with similar results in terms of toxicity and oncologic outcome.
Up to now, a simultaneous integrated boost (SIB) approach has not been fully exploited in CIRT so far. The expected benefit of a SIB planning approach in carbon ion treatment is the reduction of toxicity with respect to the sequential (SEQ) approach currently used in CNAO clinical practice, while maintaining the same local control rate. This benefit depends on the potentiality of SIB to better spare normal tissues, further enhancing the intrinsic favourable physical and radiobiological characteristics of the carbon ions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Histologically-proven primary head and neck ACC;
- •Unresectable stage or residual macroscopic disease after surgery or multiple microscopic margins after surgery;
- •Patient with resectable tumor but refusing surgery
- •cN0/pN0 - cN1/pN1 patients (only ipsilateral neck levels I and II)
- •Absence of distant metastases or oligometastatic status (patients with ≤ 3 metastatic lung or bone lesions, excluding other sites;
- •No previous radiotherapy in head and neck region;
- •Karnofsky Performance Status ≥ 70;
- •Age ≥ 18 years;
- •Written informed consent
- •Patients' ability to understand the characteristics and consequences of the clinical trial.
排除标准
- •Local conditions contraindicating CIRT (e.g., active infection or previous history of recurrent infections in or close to the tumor site; intratumoral necrosis in strict proximity of vessels; pre-existing skin, bone or soft tissue fistula; extended mucosal involvement by the tumor; previous surgery with flap reconstruction);
- •Tumour site in nasopharynx, pharynx and tongue base (where an exclusive CIRT treatment could be at high risk of toxicity);
- •Tumor disease involving ≥ 50% of the palate with consequent high risks of serious anatomical damage in case of significant and rapid disease response to CIRT
- •Nodal involvement > cN1/pN1 or cN1/pN1 outside ipsilateral levels I and II
- •Tumor surrounding carotid artery > 180° or infiltrating the vessels
- •itanium surgical implants or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and may determine uncertainties in CIRT dose distribution during treatment planning
- •Presence of any comorbidity deemed to impact on treatment toxicity;
- •Psychic or other disorders that may prevent informed consent
- •Active autoimmune disease (e.g. systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis)
- •Contraindication to MRI
- •Pregnancy or breastfeeding in progress
结局指标
主要结局
acute and sub acute toxicity as assessed by CTACE 5.0
时间窗: 90 and 180 days after radiation treatment
Acute and subacute toxicity will be assessed with clinical evaluation within 180 days after the end of treatment and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
次要结局
- local control assessed through head and neck MRI(from last day of radiation treatment up to 12 months until disease progression or death or last follow up up to 5 years)
- toxicity evaluation(toxicity assessed at 90, 120, 180 days)