Trial comparing two radiotherapy techniques in head and neck cancer

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: CMFP‐RT Comprehensive Mucosal Function Preservation Radiotherapy: Patients receive IMRT or VMAT incorporating all PRESERVE sparing objectives namely dose to buccal mucosa, tongue, skin, constrictors, salivary glands simultaneously during inverse optimisation. Dose 66 to 70Gy in 33 to 35# for a total duration of 6 to 7 weeks Control Intervention1: Standard IMRT or VMAT: Patients receive IMRT or VMAT planned per institutional standard protocol. Dose 66 to 70Gy in 33 to 35 fractions for a total duration of 6 to 7 weeks CONDITION: Health Condition 1: C148‐ Malignant neoplasm of overlappingsites of lip, oral cavity and pharyn X PRIMARY OUTCOME: To compare the composite acute toxicity rate defined as the proportion of patients experiencing any one or more of the five prespecified Grade 3+ toxicity events between the CMFP RT arm Arm B and the standard IMRT or VMAT arm Arm A during and immediately after radiotherapyTimepoint: at baseline and 6 weeks after radiotherapy SECONDARY OUTCOME: grade 2 and above mucositis, dermatitis at end of radiotherapy, dysphagia and swallowing at end of RT, 1month, 3months and 6 months following radiotherapy, grade 2 and above radiation dermatitis at end of treatment, EORTC quality of life scores, dosimetric comparison of all structures between the two armsTimepoint: at end of radiotherapy, 1 month, 2 months, 3 months, 6 months, 12 and 24 months after radiotherapy INCLUSION CRITERIA: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck oral cavity, oropharynx, nasopharynx, larynx, hypopharynx, or unknown primary cervical node, Age 18 to 70 years, ECOG Performance Status 0, 1, or 2, Planned curative‐intent RT
Epistemonikos ID: b45a723a5df883fc16bb9d84c193dae1ac4c5760
First added on: Oct 08, 2026