Radiation Dose Received by Muscles of Mastication and its Correlation with Degree of Trismus in Post-Operative Cases of Buccal Mucosa Cancers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To assess the correlation between the dose-volume parameters of the muscles of
研究概览
简要总结
We aim to study difficulty in mouth opening in operated cases of buccal mucosa undergoing Radiotherapy with or without Chemotherapy. We will collect the dose received to the muscles of mastication and TMJ by delineating them on the planning CT scan. We will assess the degree of trismus or mouth opening by measuring the distance between upper and lower central incisor teeth. We will observe the correlation between the radiation dose received by the muscles of mastication and temporo-mandibular joints of both sides and degree of trismus caused by it. Data will be collected as interincisal/interalveolar distance of patients during routine follow up periods and the dose received by the muscles of mastication and TMJ.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically proven squamous cell carcinoma of buccal mucosa.
- •Age 18 to 70 years Both sexes Karnofsky performance status 70 or above Adequate surgical resection of primary and nodal disease Nonmetastatic disease.
- •Patients planned for adjuvant chemoradiation or adjuvant radiotherapy only with dose of RT ranging from 60 to 64Gy in 30 to 32 fractions by VMAT Only patients having Maximal Inter Incisal Opening more than 25mm at the time of RT starting will be included.
- •In patients with no Incisors teeth, Inter alveolar distance will be considered.
排除标准
- •Any histopathology other than SCC Previous radiotherapy to the head and neck region Synchronous or metachronous malignancy Maximal Inter Incisal Opening less than 25mm at the time of RT starting Pregnant or lactating women Evidence of distant metastasis Recurrent or residual disease.
结局指标
主要结局
To assess the correlation between the dose-volume parameters of the muscles of
时间窗: to be assessed 1 month and 3 months Post radiation.
mastication, temporo- mandibular joint and the degree of trismus developed post radiotherapy in post-operative buccal mucosa cancers.
时间窗: to be assessed 1 month and 3 months Post radiation.
次要结局
- 1. Acute toxicities as per RTOG criteria to be assessed 1 month and 3 months Post RT.(2. Assessment of dose received by back of neck and subcutaneous tissue toxicity grading as per RTOG at 3 months, 6 months and 1-year Post-RT.)
研究者
Dr Ashutosh Mukherji
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi