Parotid sparing adaptive radiotherapy in head and neck cancer.
Phase 3
- Conditions
- Health Condition 1: C32- Malignant neoplasm of larynxHealth Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/05/052216
- Lead Sponsor
- Tata Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Pathologically proven squamous cell carcinomas of head and neck including oral cavity, oropharynx, hypopharynx, larynx and nasopharynx.
Age between 18 â?? 80 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Undergoing radical or adjuvant radiation/chemoradiation and requiring bilateral neck irradiation.
One or both parotids are intended to receive at least a dose between 25 â?? 30 Gy in the initial plan.
Exclusion Criteria
Prior surgery of the parotid glands
Prior radiation therapy to the head and neck region.
Prior cytotoxic chemotherapy
Poor candidates for regular post-treatment surveillance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean XeQoLS score changes with time between the armsTimepoint: end of treatment, 3 months, 6 months, 9 months and 12 months
- Secondary Outcome Measures
Name Time Method Disease free survivalTimepoint: Median and 2-year;Mean EORTC QLQ C30 and HN35 global quality of life, functioning and symptom burden scale changes with time between arms. <br/ ><br>Timepoint: at multiple visits done between end of RT and 12 months;Mean XeQoLS domain scores for xerostomia related physical functioning, pain or discomfort, personal / psychological functioning and social functioning changes with time between arms <br/ ><br>Timepoint: at multiple visits between end of RT and 12 months;Overall survivalTimepoint: Median and 2-year