Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Submandibular gland plus parotid sparing volumetric modulated arc therapy.: Patients with head and neck cancer receiving submandibular gland plus parotid sparing volumetric modulated ar
Sponsors
Jawaharlal institute of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years of age 2. Patients with ECOG performance status 0 - 2 3. Patients of squamous cell carcinoma of the head and neck planned for radical radiation with or without concurrent chemotherapy treated with volumetric modulated arc radiotherapy
Exclusion criteria
Exclusion criteria: 1. Patients with previous history of radiotherapy to head and neck 2. Patients with carcinoma of the head and neck in whom the submandibular glands are enclosed completely in the clinical target volume. 3. Tumour involvement of both the submandibular glands 4. Preâ??existing salivary gland disease 5. Previous or concurrent illness that would compromise completion of treatment or follow-up 6. Patient receiving prophylactic amifostine or pilocarpine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation.Timepoint: To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the correlation between relative change in the excretion rate and patient reported outcomes measured using xerostomia questionnaire (XQ)Timepoint: 3 months, 6 months and 1 year post radiation;To assess the correlation between relative change in the excretion rate and the mean submandibular doses. Timepoint: 3 months, 6 months and 1 year post radiation;To assess the correlation between the Umax and unstimulated and stimulated salivary flow rate measured by sialometry.Timepoint: 3 months, 6 months and 1 year post radiation;To assess the correlation between the relative change in the excretion rate and unstimulated and stimulated salivary flow rate measured by sialometry. Timepoint: 3 months, 6 months and 1 year post radiation;To assess the correlation between Umax and the mean submandibular doses Timepoint: 3 months, 6 months and 1 year post radiation;To assess the correlation between Umax and patient reported outcomes measured using xerostomia questionnaire (XQ)Timepoint: 3 months, 6 months and 1 year post radiation;To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not sparedTimepoint: 3months and 1 year post-radiation;To assess the excretion rate for the normal submandibular glands pre- radiation.Timepoint: Pre-radiation;To assess the maximum salivary uptake (U max) for the normal submandibular glands pre- radiationTimepoint: Pre-radiation;To assess the relative change in the excretion rate (Î?F) between patients whose submandibular glands were spared compared to those in whom they were not sparedTimepoint: 3months, 6 months and 1 year post radiation | — |
Countries
India
Contacts
Public ContactPrasoon Garg
JIPMER, Pondicherry
Outcome results
None listed