Can less radiation be safer without sacrificing cancer control?
NCT ID NCT02528955
First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This study tested whether giving lower doses of radiation after surgery for head and neck cancer could reduce long-term side effects like dry mouth and trouble swallowing, while still keeping the cancer from coming back. About 200 patients with certain stages of oral, throat, or voice box cancer received one of three reduced-radiation plans. The goal was to see if the cancer recurrence rate after two years stayed low enough to make these gentler treatments a new standard.
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 show that some patients can get lower radiation doses after surgery, reducing long-term side effects like dry mouth and swallowing problems without increasing cancer recurrence.
- What could go wrong
- This is a Phase 2 study with 200 patients, so results are not definitive. Lower radiation might lead to higher recurrence rates in some patients, and the findings may not apply to all head and neck cancers.
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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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200 people
The number who actually took part.
- Start date
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Oct 2014
- Finished
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Sep 2025
- 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. Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro- or hypopharynx 2. Postoperative tumor status: * Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b * Hypopharynx: pT1-2; pN1 3. Patients that fulfill one or both of the following criteria: * ≤ pT2, R ≥ 5 mm, L0, Pn0 * ≤ 3 ipsilateral lymph node metastases (if a contralateral adequate neck dissection is performed, no contralateral neck dissection is recommended in patients with strictly ipsilateral localised tumors of the oropharynx or oral cavity) 4. R0-Resection (resection margin ≥ 1mm) 5. No distant metastasis cM0 6. age ≥ 18 years, no upper age limit 7. ECOG ≤ 2 8. Patients that understood protocol contents and are able to behave according to protocol 9. Signed study-specific consent form prior to therapy 10. In case of indicated simultaneous chemotherapy: * adequate bone marrow function (leucocytes \> 3,5x10\^3, platelets \> 100x 10\^3, hemoglobin \> 10g/dl * sufficient liver function: bilirubin \< 2,0mg/dl, ALT, AST \< less than 3 times upper limit of normal * sufficient renal function: normal serum creatinine, glomerular filtration rate \> 60ml/min Exclusion Criteria: 1. pregnant or lactating/nursing women 2. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment 3. Any condition potentially hampering compliance with the study protocol and follow-up schedule 4. On-treatment participation on other trials 5. R1 or R2 resection status 6. pN2c and pN3 7. cM1 8. prior radiotherapy in the head and neck region , prior chemo- or immunotherapy (neoadjuvant/induction) 9. time between surgery and beginning of radio(chemo)therapy \> 6 weeks 10. Prior (\> 4 months before beginning of radio(chemo)therapy) neck dissection 11. In case of indicated simultaneous chemotherapy: * reduced hearing ability (especially upper frequency range) * known dihydropyrimidindehydrogenase (DPD) deficiency * simultaneous therapy with brivudin or other DPD-inhibitors * uncontrolled serious disease, including physical and mental diseases, for example within last 6 months:instable angina pectoris, heart attack, serious cardiac dysrhythmias, stroke, serious carotid stenosis, neurologic or psychiatric disorders including epilepsy, dementia, psychosis; uncontrolled infection; liver cirrhosis Child B or C, severe hepatic impairment; severe blood count changes; severe renal impairment, HIV
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Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
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Dept. of Radiooncology, University Hospital
Erlangen, 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