Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2CLEARNCT07755449
CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)
A Phase 2 study testing IMRT OR VMAT Radiotherapy excluding cervical radiation in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Institut Català d'Oncologia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- IMRT OR VMAT Radiotherapy excluding cervical radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jul 2026to 1 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Phase II Clinical Trial to Evaluate the Exclusion of Cervical Volumes in Postoperative Irradiation of Locally Advanced Head and Neck Squamous Cell Carcinoma
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?
Read more
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
- Being tested
- IMRT OR VMAT Radiotherapy excluding cervical radiation
- Keywords
- squamous cell carcinoma, Head and neck cancer, elective nodal irradiation omission, radiotherapy de-escalation, Neck dissection
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT OR VMAT Radiotherapy excluding cervical radiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Selective postoperative radiotherapy | Experimental | Postoperative IMRT or VMAT with selective cervical nodal irradiation based on pathological findings after neck dissection, omitting irradiation of low-risk cervical nodal levels. Receives: Radiation: IMRT OR VMAT Radiotherapy excluding cervical radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence rate in non-irradiated cervical levels
Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%)
Measured: At 24 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 6, 12, and 24 months
Treatment Adherence
Proportion of participants completing radiotherapy according to protocol, and reasons for non-completion.
Measured: Completion of radiotherapy (up to approximately 46 days)
Incidence and Severity of Lymphopenia
Will be classified according to CTCAE.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start13 Jul 2026
- Primary completion13 Jul 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755449
- Sponsor's protocol ID
- CLEAR
- Other IDs
- PR150/25
- Acronym
- CLEAR
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Evaluate the Exclusion of Cervical Volumes in Postoperative Irradiation of Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07755449
- Acronym / sponsor ID
- CLEAR / CLEAR
- Keywords
- squamous cell carcinoma, Head and neck cancer, elective nodal irradiation omission, radiotherapy de-escalation, Neck dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 13 Jul 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective postoperative radiotherapy | Experimental | Radiation: IMRT OR VMAT Radiotherapy excluding cervical radiationPostoperative IMRT or VMAT with selective cervical nodal irradiation based on pathological findings after neck dissection, omitting irradiation of low-risk cervical nodal levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRT OR VMAT Radiotherapy excluding cervical radiation30 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. | Radiation | Selective postoperative radiotherapy |
Primary outcome
Regional recurrence rate in non-irradiated cervical levels
Time frame: At 24 months
Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%)
8 secondary outcomes
Local and Regional Progression-Free Survival
Time frame: 1 and 2 years
Distant Metastasis-Free Survival
Time frame: 1 and 2 years
Overall Survival
Time frame: 1 and 2 years
Incidence of Acute and Chronic Toxicity
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)
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)
Time frame: 0, 6, 12, and 24 months
Treatment Adherence
Time frame: Completion of radiotherapy (up to approximately 46 days)
Incidence and Severity of Lymphopenia
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT OR VMAT Radiotherapy excluding cervical radiation in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Institut Català d'Oncologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Linares (+34667129210, ilinaresgaliana@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional recurrence rate in non-irradiated cervical levels (time frame: At 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.