Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
squamous cell carcinoma, Head and neck cancer, elective nodal irradiation omission, radiotherapy de-escalation, Neck dissection
Brief summary
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
Interventions
RADIATIONIMRT OR VMAT Radiotherapy excluding cervical radiation
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.
Sponsors
Institut Català d'Oncologia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years of age * ECOG Performance Status (PS) ≤ 2 * Histologically confirmed diagnosis of locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Resection of the primary tumor and unilateral and/or bilateral neck dissection performed according to standard guidelines, with detailed histological reporting by nodal level * Number of lymph nodes per dissected neck ≥ 18 * No pathological lymph nodes following neck dissection (pN0) * Presence of a single pathological cervical lymph node following neck dissection (pN1), provided that: * No extracapsular extension * Diameter \< 1 cm * No skip metastasis * Presence of risk factors indicating postoperative radiotherapy. Stages pT1-pT2N1 and pT3-pT4N0/N1. If N1, all of the following criteria must be met: presence of a single cervical lymph node without extracapsular extension, diameter \< 1 cm, and no skip metastasis * Patients may receive adjuvant systemic treatment if surgical margins are positive or close (\< 5 mm)
Exclusion criteria
* Absence of informed consent * Prior irradiation to the head and neck region * Prior surgery in the head and neck region * Contralateral neck dissection not performed when clinically indicated * History of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer * Interval between surgery and radiotherapy \> 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional recurrence rate in non-irradiated cervical levels | At 24 months | Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local and Regional Progression-Free Survival | 1 and 2 years | 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. |
| Distant Metastasis-Free Survival | 1 and 2 years | 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. |
| Overall Survival | 1 and 2 years | 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 |
| Incidence of Acute and Chronic Toxicity | 3, 6, 12 and 24 months | 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. |
| Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 0, 6, 12, and 24 months | 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. |
| Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35) | 0, 6, 12, and 24 months | 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. |
| Treatment Adherence | Completion of radiotherapy (up to approximately 46 days) | Proportion of participants completing radiotherapy according to protocol, and reasons for non-completion. |
| Incidence and Severity of Lymphopenia | Up to 24 months | Will be classified according to CTCAE. |
Countries
Spain
Contacts
CONTACTIsabel Linares
CONTACTPaula Anglada
Outcome results
None listed