Head and neck cancer Cancer
Conditions
Interventions
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Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. ECOG Performance Status =3 3. Histological diagnosis of squamous cell carcinoma, undifferentiated carcinoma, epithelial glandular and non-glandular carcinoma (including adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, neuroendocrine carcinoma, etc.) originating from the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary glands, paranasal sinuses, or from an unknown primary site. 4. Stage III–IV non-metastatic disease for pharyngeal, laryngeal, or unknown-primary tumors, according to AJCC 7th edition. Patients with stage III–IV tumors of salivary gland or paranasal sinus origin, and patients with stage I–II pharyngeal or laryngeal tumors, will only be included if prophylactic irradiation of cervical lymph node stations is indicated and/or if the oral and oropharyngeal mucosa as well as swallowing-related structures are included within the irradiated volume. 5. Indication for treatment in either definitive or adjuvant settings, with or without systemic therapy (concurrent systemic therapy, with or without prior neoadjuvant chemotherapy, permitted. Adjuvant systemic therapy is allowed for selected advanced stages of pharyngeal carcinoma, according to institutional guidelines). 6. Formal acceptance of study participation requirements (written informed consent).
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to the head-neck region. 2. Presence of connective tissue disorders (e.g., lupus erythematosus or scleroderma) or synchronous head and neck malignancies, except for superficial skin cancers or surgically treated carcinoma in situ not requiring radiotherapy or systemic therapy. 3. Absence of formal acceptance of study participation requirements (written informed consent). 4. Indication for treatment exclusively in the postoperative setting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional tumour control: The primary endpoint is local tumor control at 12 months of follow-up, considering both partial and complete responses as defined by the oncological RECIST 1.1 radiological criteria. Tumor volume analysis from MRI imaging between pre-RT and 3 months post-RT will be used to quantify tumor volume reduction (shrinkage) in patients undergoing curative radiotherapy alone. Tumor volume analysis from MRI imaging at 3, 6, and 12 months post-RT will be used to quantify tumor volume recurrence. Time Frame: 1 year following radiotherapy end | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicity: Toxicity assessment will be performed by the radiation oncologist in accordance with CTCAE v.5.0 recommendations, through the completion of questionnaires and clinical evaluation. Clinician-reported outcomes (CROs), collected weekly during radiotherapy, will be used to define longitudinal descriptors of the onset and severity of treatment-related side effects. Descriptors of interest will include mean mucositis grade, incidence of grade =3 mucositis, and maximum mucositis grade. In addition to CRO-based descriptors, the feasibility of defining quantitative toxicity descriptors will be explored through the analysis of normal tissues on MRI images by extracting textural features. Time Frame: <8 weeks from radiotherapy end | — |
Countries
Italy
Contacts
Public ContactJacopo Iacovacci
Outcome results
None listed