Health Condition 1: C32- Malignant neoplasm of larynx Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean XeQoLS score changes with time between the armsTimepoint: end of treatment, 3 months, 6 months, 9 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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 Timepoint: at multiple visits between end of RT and 12 months;Overall survivalTimepoint: Median and 2-year | — |
Countries
India
Contacts
Tata Medical Center