A Phase 2 interventional study of IMRT OR VMAT Radiotherapy excluding cervical radiation in Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Institut Català d'Oncologia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Institut Català d'Oncologia · Phase 2, Interventional, and Treatment
Among 34 studies in Carcinoma, Squamous Cell with a site in Spain — 6 open to participants now, 9 under way, 3 of them phase 3. Carcinoma, Squamous Cell · Spain.
Among the 34 studies in Carcinoma, Squamous Cell with a site in Spain, this one is the 24th largest by planned enrollment of the 30 interventional ones, is one of 2 that started in 2026, is one of 7 in phase 2, and was the 34th registered.
627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.
This study's planned enrollment of 101 is above the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →6 of the 34 studies in Carcinoma, Squamous Cell with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 100 Carcinoma, Squamous Cell studies recruiting now, 84 (84%) set no upper age limit and 8 (8%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
Median enrollment 271 across the 30 interventional studies, 167 across the 4 observational. Of the 24 that completed or were terminated, 16 (67%) have results posted.
27 of 34 have an industry lead sponsor. The 10 most frequent:
Institut Català d'Oncologia is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
Institut Català d'Oncologia has 1 study filed under Carcinoma, Squamous Cell — fewer than ten, so there is no comparison to draw.
4 of the studies in Carcinoma, Squamous Cell with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT05784012Grupo Español de Tratamiento de Tumores de Cabeza y CuelloTwo-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma | 2027-03 |
| NCT07755449Institut Català d'OncologiaCLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation) | 2027-07-13 |
| NCT06561685Eli Lilly and CompanyA Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors | 2027-10 |
Among the 34 studies in Carcinoma, Squamous Cell with a site in Spain, from their registry updates:
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:
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postoperative IMRT or VMAT with selective cervical nodal irradiation based on pathological findings after neck dissection, omitting irradiation of low-risk cervical nodal levels.
Radiation: IMRT 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.
Regional 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
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 86 non-industry phase 2 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 82. This study's planned 12 months is below that.
Counting every sponsor, half of 97 studies reached it within 61 months; a quarter within 37 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Català d'Oncologia