Could less radiation be better for head and neck cancer patients?
NCT ID NCT06030440
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving less radiation after surgery for certain head and neck cancers can reduce long-term side effects, like trouble swallowing, without allowing the cancer to come back. About 508 adults who have had surgery and need standard post-op radiation will be randomly assigned to either the usual radiation or a reduced version that skips some neck areas. The goal is to see if the gentler approach leads to fewer feeding tube dependencies and similar cancer control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If successful, this could lead to a new standard of care that reduces long-term side effects like swallowing problems for head and neck cancer patients.
- What could go wrong
- This is an early-to-mid stage trial, so results are not guaranteed. Reducing radiation might increase the risk of cancer returning in untreated 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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 508 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Sep 2033
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: 1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0)) 2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard 3. Indication for postoperative radio(chemo)therapy 4. No lymph node metastases \> 6cm 5. Lymph node metastases in not more than 3 lymph node level 6. No distant metastases (cM0) 7. Age ≥ 18 years, no upper age limit 8. Eastern Cooperative Oncology Group (ECOG) ≤ 2 9. Patients who understood protocol contents and are able to behave according to protocol 10. Signed study-specific consent form prior to therapy 11. Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications) Exclusion Criteria: 1. macroscopic incomplete resection R2 2. Distant metastases (cM1) 3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy) 4. Lymph node metastases in \> 3 lymph node level 5. pregnant or lactating/nursing women 6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment 7. Any condition potentially hampering compliance with the study protocol and follow-up schedule 8. On-treatment participation on other clinical therapeutic trials 9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction)) 10. Patients who have contraindication for MRI and CT with contrast agent (both) 11. Prior (\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage 12. History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease
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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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Universitätsklinikum Erlangen, Strahlenklinik
RECRUITINGErlangen, Bavaria, 91054, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Glowing dye lights up throat tumors during surgery
- Lighting up oral cancer: dye may help surgeons see tumor edges
- MRI-Guided tweaks during radiation could spare throat cancer patients from swallowing woes
- Can a One-Two punch of immunotherapy and radiation wipe out head and neck tumors before surgery?
- Mouth rinse could ease painful radiation side effects for head and neck cancer patients