To study the clinical variations and dose volume changes with adaptive radiotherapy in head and neck cancers
- Conditions
- Malignant neoplasms of lip, oral cavity and pharynx,
- Registration Number
- CTRI/2021/09/036417
- Lead Sponsor
- svims tirupati
- Brief Summary
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
1. Acute toxicites : mucositis, dermatitis, dysphagia, voice changes, and xerostomia
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
- histopathologically proven squamous cell carcinoma of head and neck 2.cancers of oralcavity, oropharynx, hypopharynx and larynx 3.
- stage 3 to stage 4b disease 4.
- patients with ECOG performance status 0 to 2 5.
- patients who has given approved informed consent.
- patients previously treated with surgery, chemotherapy or radiotherapy 2.
- patients with distant metastasis 3.patients with ECOG performance status 3 and 4 4.pregnant women and lactating mothers.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AIM 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 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 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 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 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 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 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 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 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 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 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) 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
sri venkateswara institute of medical sciences
🇮🇳Chittoor, ANDHRA PRADESH, India
sri venkateswara institute of medical sciences🇮🇳Chittoor, ANDHRA PRADESH, IndiaDr sravanthi budithiPrincipal investigator9618083516sravanthibudithi8@gmail.com