Could skipping some neck radiation spare patients side effects?
NCT ID NCT07755449
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing whether it is safe to skip radiation to certain low-risk areas of the neck after surgery for head and neck cancer. The goal is to see if this approach can reduce side effects and preserve quality of life while still keeping the cancer from coming back. Participants will receive standard radiation to the main tumor area, but not to the neck regions that were surgically cleared of cancer. The study will compare their outcomes to historical data from patients who received full neck radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiotherapy (IMRT or VMAT) that selectively omits radiation to low-risk neck areas, with optional concurrent cisplatin chemotherapy
- What this could lead to
- If successful, this approach could reduce side effects and improve quality of life for head and neck cancer patients after surgery, without increasing the risk of cancer returning.
- What could go wrong
- This is a phase II trial with a modest number of patients, and the strategy may not be as effective as standard radiation in preventing cancer recurrence. There is also a risk of increased recurrence in the omitted areas.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 101 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institut Català d'Oncologia
RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08908, Spain
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Other studies related to the condition(s) this trial covers.
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- Can immunotherapy before surgery shrink head and neck tumors?
- Can an immunotherapy plus radiation outsmart head and neck cancer?
- Cutting radiation after surgery: a new hope for head and neck cancer patients?
- Can a new drug boost radiation's power against head and neck cancer in older patients?
- New combo therapy targets tough head and neck cancers