Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Submandibular plus parotid sparing: Patients with head and neck cancer receiving submandibular gland plus parotid sparing volumetric modulated arc therapy everyday except Saturday and S
Sponsors
JIPMER
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 T1N0M0 carcinoma glottis 3. Patients with carcinoma of the head and neck in whom the submandibular glands are enclosed completely in the clinical target volume. 4. Tumour involvement of both the submandibular glands 5. Preâ??existing salivary gland disease 6. Previous or concurrent illness that would compromise completion of treatment or follow-up 7. Patient receiving prophylactic amifostine or pilocarpine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of sparing the submandibular gland on patient reported outcomes measured subjectively using xerostomia questionnaire XQ in head and neck cancer patients receiving Submandibular and Parotid sparing versus Parotid sparing using Volumetric modulated arc therapy VMATTimepoint: Pre radiation as baseline and at 3 months and at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the dosimetric parameters of the VMAT plans in both armsTimepoint: Dosimetric parameters will be analysed at the completion of study in both arms;To assess the effect of sparing the submandibular gland on salivary gland function measured objectively by measuring the unstimulated and stimulated salivary secretion by using sialometryTimepoint: Pre radiation as baseline and at 3 months and at 6 months;To assess the effect of sparing the submandibular gland on salivary gland function measured objectively using salivary scintigraphyTimepoint: Pre radiation as baseline and at 3 months and at 6 months;To assess the progression free survival and overall survival in both armsTimepoint: At 6 months;To assess the proportion of patients developing acute and late side effects of salivary gland radiation using acute and late RTOG toxicity scoring criteriaTimepoint: Acute RTOG toxicity after every 5 fractions of radiation and at 6 weeks post radiation Late RTOG toxicity will be assessed at 6 months post radiation;To assess the proportion of patients developing acute and late side effects of salivary gland radiation using the CTCAE version 5.0Timepoint: Acute toxicity after every 5 fractions and at 6 weeks post radiation Late CTCAE toxicity will be assessed at 6 months post radiation;To compare the locoregional control in both arms assessed by CECT head and neck 6 monthsâ?? post radiationTimepoint: Locoregional recurrence will be assessed at 6 months post radiation;To compare the quality of life in both arms using EORTC QOL 30 and EOTC QOL 35 questionnaire version 3.0Timepoint: Pre radiation as baseline and at 3 months and at 6 months;To compare the response of the tumour to radiation in both arms, assessed by CECT head and neck 3 months post radiation using the RECIST criteriaTimepoint: Response assessment using PETCT scan at 3 months | — |
Countries
India
Contacts
Public ContactDr MUTHUVEERAPPAN S
Jawaharlal institute of postgraduate medical education and research
Outcome results
None listed