A prospective study to evaluate the clinical outcomes and dose volume histogram (DVH) parameters of adaptive intensity modulated radiotherapy in the treatment of patients with head and neck cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- AIM
研究概览
简要总结
AIM OF THE STUDY : To evaluate clinical outcome variations and dose volumetric changes with adaptive rt in head and neck cancers
OBJECTIVES : To document and assess the following parameters
-
Acute toxicites : mucositis, dermatitis, dysphagia, voice changes, and xerostomia
-
Clinical response rate : changes in gross tumor volume and changes in nodal volume
3.dose volumetric parameters : dose to parotid gland and dose to spinal cord
all patients will undergo CT simulation and treatment planning by IMRT initially, and will be reviewed weekly basis while RT is going on for grading acute toxicities.
During the course of treatment patient will undergo rescan and replanning around 23 fractions and dose volume changes are compared with initial scan for gross tumor volume, nodal volume, dose to parotid gland and dose to spinal cord
During thetime period between March 2021 to December 2022, after histopathologicalconfirmation 64 patients were recruited into the study after screening andexcluding the patients based on exclusion criteria. Pre-treatment evaluationdone in all patients before starting RT. Planning CT was taken with Siemens AS 20 CT simulator and the images weretransferred to the MONACO treatment planning systems. All the patients weretreated with Elekta synergy linear accelerator (Elekta, Stockholm) with IMRT.In 64 patients, 43 patients received 66Gy and 21 patients received 70Gy. After22# all patients underwent re CT simulation and replanning
· The Mean GTV-P volume is 59.03ccin Initial plan and 41.24cc in the Replan with a mean reduction of 30.4%.
· Mean GTV-N is 48.98cc ininitial plan and 31.09cc in Replan with mean reduction of 36.2%.
· We achieved reduced volume of tumourwas calculated to be at the rate of 1.11% per day.
· The mean reduction in the Dmax SpinalCord dose, Dmean Right Parotid and Dmean Left Parotid 3.4%, 6.3% and 4.5%respectively. The Above values were found to be statistically significant
· V95% is more than 95% and v107%is less than 2% in both initial and replans.
The observed acute radiation induced toxicities in our studies weremucositis, dermatitis, dysphagia, xerostomia and voice changes. Most of thepatients had grade 2 and grade 3 acute toxicities. Maximal grading in acutetoxicities; Mucositis is Grade 2-38/64 (59.37%), Dermatitis is Grade 2-46/64(71.87%), Dysphagia is Grade 2-37/64 (57.8%), Voice changes is grade 2-29/64(57.8%), Xerostomia Grade 1 is 50/64 (78.1%). No one experienced grade 3, grade4 xerostomia. There were no deaths during the course of treatment.
All 64 patients underwent response evaluation in 8-10weeks after thecompletion of treatment. In those 56.25% patients had complete response, 32.81%patients had partial response, 7.81% patients had progressive disease and 3.12%patients had stable disease.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •histopathologically proven squamous cell carcinoma of head and neck 2.cancers of oralcavity, oropharynx, hypopharynx and larynx
- •stage 3 to stage 4b disease
- •patients with ECOG performance status 0 to 2
- •patients who has given approved informed consent.
排除标准
- •patients previously treated with surgery, chemotherapy or radiotherapy
- •patients with distant metastasis 3.patients with ECOG performance status 3 and 4 4.pregnant women and lactating mothers.
结局指标
主要结局
AIM
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
To evaluate clinical outcome variations and dose volumetric changes with adaptive IMRT in head and neck cancers
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
objectives
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
to document and assess following parameters
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
1. acute toxicities
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
a) mucositis
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
b) dermatitis
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
c) dysphagia
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
d) voice changes
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
e) xerostomia
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
2. clinical responce rate
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
a) changes in gross tumor volume (GTV)
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
b) changes in nodal volume
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
3. Dose volumetric parameters
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
a) dose to parotid gland
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
b) dose to spinal cord
时间窗: all the patients will undergo CT simulation and treatment planning by IMRT | patients will be assessed baseline and weekly basis during RT for acute toxicities | patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan
次要结局
未报告次要终点