The goal of this clinical trial is to learn if selectively omitting postoperative cervical irradiation is a safe and feasible treatment strategy for patients with resected, locally advanced squamous cell carcinoma of the head and neck (HNSCC) who underwent systematic neck dissection and have no high-risk nodal factors. The main questions it aims to answer are: * Is the regional recurrence rate with selective omission of postoperative cervical irradiation non-inferior to the recurrence rate reported with standard complete nodal irradiation (6-8%)? * Does selective omission of postoperative cervical irradiation reduce toxicity? * Does selective omission of postoperative cervical irradiation improve immunological preservation and quality of life? Researchers will compare outcomes in participants treated with this selective irradiation strategy to previously published data and to a retrospective institutional cohort treated with standard complete nodal irradiation, to see if it maintains regional control while reducing toxicity and preserving immune function and quality of life. Participants will: * Receive postoperative radiotherapy according to the new protocol, omitting irradiation of low-risk nodal levels * Receive concomitant chemotherapy if clinically indicated, per standard practice * Visit for checkups, blood sample collection, to complete quality-of-life questionnaires and attend follow-up visits over 48 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
30 or 33 sessions of radiotherapy 2 Gy sessions until 60 or 66 Gy will be administered to the primary tumor bed. Concomitant cisplatin chemotherapy may be administered per standard clinical practice in patients with high-risk primary tumor features (positive or close \[\<5 mm\] margins), when not clinically contraindicated.
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGRegional recurrence rate in non-irradiated cervical levels
Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%)
Time frame: At 24 months
Local and Regional Progression-Free Survival
Will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis.
Time frame: 1 and 2 years
Distant Metastasis-Free Survival
Distant metastasis-free survival will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis.
Time frame: 1 and 2 years
Overall Survival
will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis
Time frame: 1 and 2 years
Incidence of Acute and Chronic Toxicity
Will be assessed using CTCAE v5.0. Cumulative incidence will be analyzed by grade and affected organ/system along with prevalence, in the safety population.
Time frame: 3, 6, 12 and 24 months
Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at each time point compared with baseline in the intention-to-treat population. The questionnaire employs 28 items rated on 4-point Likert scales and two items rated on 7-point Likert scales, with response options ranging from "Not at all" to "Very much" and from "Very poor" to "Excellent", respectively. Scores are linearly transformed to a 0-100 scale. For the functional scales and the Global Health Status/Quality of Life scale, higher scores indicate better functioning or quality of life, whereas for the symptom scales, higher scores indicate greater symptom burden.
Time frame: 0, 6, 12, and 24 months
Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H\&N35) at each time point compared with baseline in the intention-to-treat population. The questionnaire employs 30 items rated on 4-point Likert scales, with response options ranging from "Not at all" to "Very much", and five dichotomous (Yes/No) items. Scores are linearly transformed to a 0-100 scale, where higher scores indicate greater symptom burden.
Time frame: 0, 6, 12, and 24 months
Treatment Adherence
Proportion of participants completing radiotherapy according to protocol, and reasons for non-completion.
Time frame: Completion of radiotherapy (up to approximately 46 days)
Incidence and Severity of Lymphopenia
Will be classified according to CTCAE.
Time frame: Up to 24 months
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