Phase II Open Label Study to Investigate Impact of Adaptive Radiotherapy on Quality of Life Score in Patients with Locally Advanced Head and Neck Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To assess the quality of life in Locally advanced Head and Neck cancer patients undergoing IMRT/Chemo-IMRT with mid treatment adaptive replanning
研究概览
简要总结
Head and neck carcinoma is one of the most common cancers with a global incidence of 6,57,438 and mortality of 3,36,360 in 2018, accounting for 3.6% of all cancer cases and 3.6% of all cancer cases. In India, Head and Neck cancers account for 30% of all cancers. The standard radiotherapy techniques for the treatment of head and neck squamous cell carcinomas (HNSCC) are highly conformal, modulated techniques such as helical IMRT (Tomotherapy), volumetric modulated arc therapy (VMAT) and intensity modulated radiation therapy (IMRT).
Many patients during the course of radiation treatment develop significant anatomic changes, hence doses to target volumes and normal structures during the course may differ significantly compared to the initial computed tomography (CT) images obtained before the treatment-which is the base of planning of treatment. By 2nd week of radiotherapy during a course of chemoradiotherapy most significant volumetric changes and dosimetric alterations in the tumour volumes and organs at risk occur. IMRT plans based on a single planning CT dataset may lead to unexpected complications and/or to marginal geographic misses of target volumes.
A possible strategy to overcome these limitations is Adaptive radiotherapy (ART). ART is a novel approach which uses repeat imaging and re-planning to adapt to actual patient anatomy.
Published data on adaptive radiotherapy is limited in India due to technical and logistic challenges. Literature have shown that Adaptive Radiotherapy reduces the dose to the OARs and thus reduces the toxicity. As IMRT improves QoL by reducing doses to OARs & adaptive replanning has shown to further improve, we hypothesize that adaptive radiotherapy will improve QoL in Locally advanced head and neck cancers over and above to that with IMRT alone in locally advanced H&N cancers.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histologically proven Squamous Cell Carcinoma of head and neck region
- •Age <70 years
- •Primary tumour sites in oral cavity, oropharynx, hypopharynx and larynx.
- •4.Stage III-IVB by AJCC Cancer Staging Manual Eight Edition, 2018 5.Eastern Cooperative Oncology Group (ECOG) performance status ≤2 6.All patients fit for chemo-radiation/Radiation Therapy.
排除标准
- •Patients with resection of the primary tumour or recurrent disease
- •Patients with distant metastasis
- •Patients who have received prior NACT or surgery 4.
结局指标
主要结局
To assess the quality of life in Locally advanced Head and Neck cancer patients undergoing IMRT/Chemo-IMRT with mid treatment adaptive replanning
时间窗: 6 months
次要结局
- 1. To asses acute toxicity during 6 weeks in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning(2. To assess the incidence of xerostomia at 6 months in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning)